ROLE OF OVARIAN ADNEXAL REPORTING

DATA SYSTEM (ORADS) FOR EVALUATION

OF ADNEXAL PATHOLOGIES AND
COMPARISON WITH IOTA-ADNEX MODEL

Protocol of thesis to be submitted to University of Delhi towards partial fulfillment

of requirement for the degree of DOCTOR OF MEDICINE(RADIO-DIAGNOSIS)
Session: 2021-2024

BY

DR. ANJU CHAUDHARY

Department of Radio-Diagnosis
University College of Medical Sciences & GTB Hospital
Delhi- 110095

Protocol of thesis to be submitted to the University of Delhi towards the partial

fulfillment of the requirement for the degree of Doctor of Medicine (Radio-
Diagnosis)
Batch 2021-2024

1
ROLE OF OVARIAN ADNEXAL REPORTING
DATA SYSTEM (ORADS) FOR EVALUATION
OF ADNEXAL PATHOLOGIES AND
COMPARISON WITH IOTA-ADNEX MODEL

Student: - Dr. Anju Chaudhary ___________________

(Signature)

Supervisor: - Dr. Anupama Tandon ___________________

Professor (CAS) (Signature)
Department of Radio-Diagnosis

Co-supervisor: - Dr. Sandhya Jain __________________

Professor (Signature)
Department of Obstetrics and Gynecology

Co-supervisor: - Dr. Vinita Rathi

Director Professor ___________________
Department of Radio-Diagnosis (Signature)

Place of work: -
Departments of Radio-Diagnosis, Obstetrics and Gynecology
UCMS and GTB Hospital, Delhi-110095

2
 SUMMARY OF PROTOCOL

Title: Role of Ovarian Adnexal Reporting and Data System (ORADS) for evaluation of adnexal

pathologies and comparison with IOTA-ADNEX model.

Rationale: Various models have been proposed for prediction of malignancy in adnexal lesions.

However, most of them lack standardization of terminology and definitions to differentiate benign

and malignant. The Ovarian-Adnexal Reporting and Data System (O-RADS) ultrasound (US) risk

stratification and management system was first published by the American College of Radiology

in 2020, providing standardized terminology for evaluation of ovarian and adnexal masses, aiding

risk stratification, and providing management guidelines for different categories of lesions. Several

retrospective studies have validated this system as an effective and excellent diagnostic tool for

predicting malignancy risk. However, prospective studies are scanty and there is no Indian

literature available.

Aim: - To assess the role of ORADS for evaluation of adnexal masses and in predicting

malignancy and its comparison with IOTA-ADNEX model.

Objectives: -

Primary Objectives

1. To characterize adnexal lesions based on ORADS and to study the malignancy rate in different

grades.

2. Assess the diagnostic performance of ORADS for predicting malignancy in adnexal lesions.

3. To assess the diagnostic performance of IOTA-ADNEX model for predicting malignancy.

4. To compare ORADS with IOTA-ADNEX model for preoperative prediction of malignancy.

Secondary Objectives

1. To assess the inter-reviewer agreement for ORADS classification of adnexal lesions.

3
Setting: -Departments of Radio-Diagnosis, and Obstetrics and Gynecology, University College of

Medical Sciences and Guru Teg Bahadur Hospital, Delhi.

Study Design: -Cross sectional comparative study.

Participants: Inclusion Criteria: - Female patients of all ages

1. with clinical suspicion of adnexal lesion where ultrasound detects an adnexal lesion

2. Patients with adnexal lesions documented on previous imaging

Exclusion Criteria: -

1. Patients with physiological cysts (follicular/corpus luteal cyst).

2. Patients with already diagnosed/operated cases with recurrences.

3. Patients with ectopic pregnancy.

4. Patient, who were not given consent for participation in the study

5. Patients who lost for further follow up USG or higher investigation to confirm the

diagnosis.

Sample Size: - As there is no study which can give exact prevalence of adnexal lesions and here

in this study we are taking different varieties of adnexal lesions (benign/malignant/infective), exact

sample calculation is not possible. So convenient sample size of minimum of 100 patients is being

taken.

Methods: -After obtaining the relevant history and written informed consent, Transvaginal USG

complemented with transabdominal approach will be performed in every patient and findings will

be recorded which are then graded according to ORADS and IOTA-ADNEX model, final

diagnosis is then confirmed with histopathological diagnosis/ higher investigations/ follow-up

scans.

Statistical Test: - Results will be subjected to appropriate statistical test.

4
 INTRODUCTION

Adnexal mass lesions are fairly common among women with a prevalence of 0.17% to 5.9% in

asymptomatic women and 7.1% to 12% in symptomatic women of all age groups (1). Ovarian

cancer has an incidence of 6.6 and has the highest mortality rate and most unfavorable prognosis

among the gynecological malignancies; the average 5-year survival rate is <50% (2,3). The main

cause of mortality is late diagnosis at an advanced stage, due to lack of symptoms during early

disease, as well as inadequate or nonexistent screening techniques.

Transvaginal USG complemented with transabdominal approach remains the primary imaging

modality for evaluating gynecological abnormalities (4). It is widely available, relatively in-

expensive, non-ionizing imaging modality well accepted by the patients.

MRI though has superb soft tissue contrast, is expensive and less readily available and is helpful

when sonographic characteristics are indeterminate. CT is primarily used in the staging of pelvic

malignancy, monitoring response to treatment and usually does not play a role in diagnosis.

Subjective assessment by ultrasound finding by specialists in gynecological ultrasonography is

one of the means of evaluating adnexal masses in clinical practice. But inconsistency in the use of

morphologic imaging descriptors and definitions often results in significant differences in

subsequent interpretations.

Various mathematical models, scoring systems and software programs that based on sonographic

findings were proposed for differentiation between benign and malignant ovarian tumors but till

now there is no scoring system that has been accepted as gold standard for predicting the ovarian

lesions at risk. Some being- The Risk of Malignancy Index (RMI), IOTA-SRs (simple

ultrasound-based rules or Simple Rules) model (5), IOTA-ADNEX (Assessment of Different

5
Neoplasia’s in the adnexa) model (6), Gynecologic Imaging Reporting and Data System (GI-

RADS) in 2009.

However, though some of these models have high accuracy in differentiating benign from

malignant there is lack of consistency of terminology, definitions and standardized descriptors.

Consequently, the need remains for a universally recognized standard reporting tool that will be

accurate, useful and inclusive of all pertinent descriptors and definitions. This would promote

understanding of standardized descriptors leading to reliable and reproducible morphologic end

points and diagnosis.

Recently, the American college of Radiology (ACR) published the ovarian-adnexal reporting and

data system (ORADS) in 2018, which provides an up to date suggestion to stratify the adnexal

masses according to sonographic features. The ORADS offer a comprehensive algorithm that

categorizes adnexal masses by their possibility of being normal (ORADS-1), to high risk of

malignancy (ORADS-5). With O-RADS US working group consensus, guidelines for

management in the different risk categories are proposed. At this time, O-RADS US is the only

lexicon and classification system that encompasses all risk categories with their associated

management schemes.

O-RADS compares favorably with GI-RADS and has a higher sensitivity than GI-RADS and

IOTA simple rules with relatively similar specificity and reliability (14). In a study (9) of ORADS

correlation with pathological diagnosis, the sensitivity and specificity were 52%, and 84%

respectively.

6
 LACUNAE IN EXISTING LITERATURE

 No Indian study is available on efficacy of different methods in characterization and

management of adnexal masses.

 Only few studies are there which have compared ORADS with previously given method for

characterization and management of adnexal masses.

 Most of the validation studies available are retrospective in nature and only a solitary study

was found which prospectively compared ORADS with pathological diagnosis.

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 REVIEW OF LITERATURE

Ovarian-Adnexal Reporting Lexicon for Ultrasound: A White Paper of the ACR Ovarian-

Adnexal Reporting and Data System Committee (7) stated that Ultrasound is the most commonly

used imaging technique for the evaluation of ovarian and other adnexal lesions. The

interpretation of sonographic findings is variable because of inconsistency in descriptor

terminology used among reporting clinicians. The use of vague terms that are inconsistently

applied can lead to significant differences in interpretation and subsequent management

strategies. A committee was formed under the direction of the ACR initially to create a

standardized lexicon for ovarian lesions with the goal of improving the quality and

communication of imaging reports between ultrasound examiners and referring clinicians. The

ultimate objective will be to apply the lexicon to a risk stratification classification for consistent

follow-up and management in clinical practice. This white paper describes the consensus process

in the creation of a standardized lexicon for ovarian and adnexal lesions and the resultant

lexicon.

In a study by 'Timor and Tritsch et al' (8), it was demonstrated that the use of a morphologic

scoring system in conjunction with color Doppler ultrasound afford better differentiation of

benign and malignant ovarian masses than the use of either procedure alone.

Solis et al (9) evaluated 73 transvaginal ultrasound records with adnexal masses and applied the

O-RADS system and compared against definitive histopathology diagnosis-RADS sensitivity for

detection of ovarian cancer was 52%, with a specificity of 84%, negative predictive value of

79%, and positive predictive value of 60%, with an accuracy of 73%.

8
Hack K et al 2022 Jul (10) - 227 women with 262 ovarian or adnexal lesions were evaluated. Of

these lesions, 71% were benign and 29% were malignant. The proportion of malignancy was 0%

for O-RADS 2, 3% for O-RADS 3, 35% for O-RADS 4, and 78% for O-RADS 5. The area under

the ROC curve (AUC) for O-RADS and ADNEX was 0.91 and 0.95, respectively. The addition

of acoustic shadowing as a benign finding improved O-RADS AUC to 0.94. Use of O-RADS 4

as a threshold yielded a sensitivity of 99% and a specificity of 70%. He concluded that ORADS

enabled accurate distinction of benign from malignant ovarian and adnexal lesions.

Cao L et al 2021 Jul (11)- studied 1054 adnexal lesions, 750 were benign and 304 were

malignant. The optimal cutoff value for predicting malignancy was >O-RADS 3 with a

sensitivity and specificity of 98.7% and 83.2 respectively. The inter-observer agreement between

a less-experienced and an expert radiologist of O-RADS categorization was good (κ = 0.714).

Jha P et al 2022 (12)- This study included 913 women with 1014 adnexal lesions. The overall

frequency of malignant neoplasm was 8.4%. The frequency of malignant neoplasm for O-RADS

US 2 was 0.5%. O-RADS US 4 was the optimum cutoff for diagnosing cancer with sensitivity of

90.6%, specificity of 81.9%, positive predictive value of 31.4% and negative predictive value of

99.0%.

Lai HW et al 2022 Jun (13) used a total of 734 AMs, including 564 benign masses, 69 borderline

masses, and 101 malignant masses were included in this study. O-RADS (0.88) and GI-RADS

(0.90) had lower sensitivity than ADNEX (0.95) (P < .05), and the PPV of O-RADS (0.98) was

higher than that of ADNEX (0.96) (P < .05). These three systems showed good IRA.

In retrospective multicentric study by Mohammad Abd Alkhalik Basha et al 2021 Feb (14)

using A total of 609 women with 647 AM were included (178 malignant and 469 benign).

9
Malignancy rates were comparable to recommended rates by previous literature in O-RADS and

IOTA, but higher in GI-RADS. O-RADS had significantly higher sensitivity for malignancy than

GI-RAD and IOTA (p = 0.003 and 0.0007, respectively), but non-significant slightly lower

specificity (p > 0.05). O-RADS, GI-RADS, and IOTA showed similar overall IRA O-RADS

compares favorably with GI-RADS and IOTA.

Pi Y et al 2021 Oct (15) stated Excellent specificities (92 to 100%), NPVs (92 to 100%), and

variable sensitivities (72 to 100%), PPVs (66 to 100%) were observed. Considering O-RADS 4

and O-RADS 5 as predictors of malignancy, individual reader AUC values range from 0.94 to

0.98 (p < 0.001). Overall inter-reader agreement for all 3 readers was "very good," k = 0.82 (0.73

to 0.90, 95% CI, p < 0.001). Pair-wise agreement between readers were also "very good," k =

0.86-0.92. 14 out of 150 lesions were misclassified, with the most common error being down-

scoring of a solid lesion with irregular outer contours.

Peng XS et al 2021 (16) stated that of the 224 patients, 53.1% developed benign tumors and

46.9% had malignant tumors. When the cut-off value for malignancy risk was 10%, the ADNEX

model including CA 125 achieved a sensitivity of 94.3%, specificity of 74.0%, positive

predictive value of 76.2%, negative predictive value of 93.6%, diagnostic odds ratio of 45.25,

and an AUC of 0.94 for differentiating between benign and malignant ovarian tumors. The

accuracy of the ADNEX model for the diagnosis of ovarian tumors of all subtypes exceeds 80%

when CA 125 measurements were included in the application, but the sensitivity for diagnosing

borderline, stage I, and metastatic ovarian tumors was only 60.0% 28.6% and 45.5%

Huang X, Wang Z, Zhang M and Luo H (2021) (17) Diagnostic Accuracy of the ADNEX Model

for Ovarian Cancer at the 15% Cut-Off Value: A Systematic Review and Meta-Analysis. In these

10
280 studies were initially retrieved through the search strategy, and 10 eligible studies were

ultimately included. The random-effects model was selected for data synthesis. The pooled

sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio

and the area under the summary receiver operating characteristic curve for ADNEX model were

0.92, 0.82, 5.2, 0.10, 54.0 and 0.95, Concluding that The ADNEX model at the 15% cut-off had

high diagnostic accuracy in identifying ovarian cancer.

Qian L et al 2021(18) To discriminate benign and malignant tumors, areas under the ROC curves

(AUCs) for ADNEX models were 0.94 with CA125 and 0.94 without CA125, which were

significantly higher than the AUCs for RMI I-III: 0.87, 0.83, and 0.82, (all P < 0.0001). At a cut-

off of 10%, the ADNEX model with CA125 had the highest sensitivity compared with the other

models.

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 AIM AND OBJECTIVES

AIM: - To assess the role of ORADS for evaluation of adnexal masses and in predicting

malignancy and its comparison with IOTA-ADNEX model.

OBJECTIVES: -

PRIMARY OBJECTIVES: -

1. To characterize adnexal lesions based on ORADS and to study the malignancy rate in

different grades.

2. Assess the diagnostic performance of ORADS for predicting malignancy in adnexal

lesions

3. To assess the diagnostic performance of IOTA-ADNEX model for predicting

malignancy.

4. To compare ORADS with IOTA-ADNEX model for preoperative prediction of

malignancy.

SECONDARY OBJECTIVES: -

1. To assess the inter-reviewer agreement for ORADS classification of adnexal lesions.

12
 MATERIALS AND METHODS

Study Setting: -The study will be conducted in Departments of Radio-diagnosis, Obstetrics and

Gynecology and Pathology of University College of Medical Sciences and Guru Teg Bahadur

Hospital, Delhi.

Sample size: - As there is no study which can give exact prevalence of adnexal lesions and here

in this study we are taking different varieties of adnexal lesions (benign/malignant/infective), exact

sample calculation is not possible. So convenient sample size of minimum of 100 patients is being

taken.

Type of study: - Comparative study

Study design: - Cross sectional

Participants:

Inclusion Criteria: - Female patients of all ages-

 with clinical suspicion of adnexal lesion where ultrasound detects an adnexal lesion

 Patients with adnexal lesions documented on previous imaging

Exclusion Criteria: -

1. Patients with physiological cysts (follicular/corpus luteal cyst).

2. Patients with already diagnosed/operated cases with recurrences.

3. Patients with ectopic pregnancy.

4. Patient, who were not given consent for participation in the study & patients who lost for

further follow up usg or higher investigation to confirm the diagnosis.

Method: -

After approval from the Institutional Ethics Committee and taking written informed

13
 consent from the patient, the study will be carried out in the Department of Radio-

diagnosis, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi

along the following lines:

Patients enrolled from the obstetrics and gynecology OPD/ward

History, general physical examination and systemic examination

Laboratory investigations (CA-125 and other investigations)

Ultrasound examination (TVS+/-TAS) with Color Doppler

MRI and CECT (if required by the gynecologist for patient management)

ORADS grading to be done based on ultrasonographic findings

Management as advised by clinician (surgical, medical or follow-up with higher investigations or

review USG)

Histological examination (FNAC/biopsy/surgical specimen)

Final diagnosis to be made based upon histopathological findings/FNAC/follow-up/higher

investigations

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CLINICAL EVALUATION A detailed history was taken with emphasis on age, sex, duration of

symptoms, presence of lump and specific complaints like pain abdomen, abdominal distension,

menstrual irregularity etc. Family history and personal history was also recorded and a thorough

clinical examination was done. All patients were subjected to diagnostic modalities after

informal consent, for confirmation of diagnosis and additional information.

LABORATORY INVESTIGATION Relevant laboratory investigations were done as and when

needed.

RADIOLOGICAL EVALUATION After obtaining the informed consent, all patients were

subjected to ultrasound and color doppler sonography, for confirmation of diagnosis. MR

imaging was subsequently performed, where diagnosis of pelvic mass lesion on USG were

inconclusive. If required, CT was done upon the requirement of case. Specific characteristics of

different pelvic masses of gynecological origin on these modalities were analyzed for making a

radiological diagnosis. Imaging diagnosis was correlated with FNAC and surgical

histopathological findings, if subjected for it. All the data and radiological features were

recorded in the set proforma.

ULTRASONOGRAPHY AND COLOR DOPPLER SONOGRAPHY- As USG being most

widely used diagnostic modality, all the clinically positive patient referred to our department of

radiodiagnosis or patients with incidentally detected pelvic mass were subjected for this

examination and included in the study after considering the exclusion and inclusion criterion.

USG examination of the pelvis was done in these patients on SAMSUNG USG machine with 6

hours of fasting and full bladder in supine position to ensure good visualization of female genital

tract. TAS was performed with 3.5-5 MHz curvilinear transducer through the distended urinary

15
bladder using coupling gel for a good skin transducer contact and TVS was done in proper

position and technique with 5-7 MHz trans vaginal probe in married patients wherever required

on USG machine. Those pelvic masses arising from gynecological origin were further studied.

Ultrasonography in sagittal and longitudinal planes was done to assess: -

a. size/shape/echogenicity/bilaterality/solid or cystic

b. cystic-no. of cysts/septations/inner wall structure/wall thickness

c. solid- size/shape/nodules/calcification/vascularity/internal structure

d. Color Doppler scoring- No flow (color score=1), minimal flow (color score=2), moderate flow

(color score=3), very strong flow (color score=4).

e. relationship to the surrounding structures/ cul-de-sac fluid.

f. associated ascites, adenopathy, peritoneal deposits, hydronephrosis, pleural effusion,

metastatic deposits in abdominal organs or any other abdominal pathology

16
A. OVARIAN ADNEXAL REPORTING AND DATA SYSTEM (O-RADS) US RISK
STRATIFICATION AND MANAGEMENT SYSTEM;

17
18
 B. IOTA ADNEX MODEL

Clinical variables-

1. Age
2. Serum CA-125 levels
3. The type of center (oncology center vs other hospitals)

Ultrasound predictors-

1. Maximum diameter of the lesion

2. The proportion of solid tissue
3. More than 10 cyst locules
4. Number of papillary projections
5. Acoustic shadows
6. Ascites

PATHOLOGY The cytopathological and post-surgical histopathological diagnosis were

recorded for correlation and data analysis.

Outcome measures: -

Primary outcome measures:

1. Percentage of patients and malignancy rate in various ORADS grades

2. Sensitivity and specificity of ORADS for differentiating benign and malignant.

3. Sensitivity and specificity of IOTA-ADNEX for differentiating benign and malignant.

4. Comparison of ORADS and IOTA-ADNEX models for risk assessment

Secondary outcome measures:

1.Interobserver agreement for ORADS grading for adnexal lesions.

Stastical analysis: -

 The prevalence of malignancies in different grades of ORADS will be expressed as

percentage.

 The sensitivity /specificity of ORADS in differentiating benign amd malignant adnexal

lesions will be calculated.

 The sensitivity /specificity of IOTA-ADNEX in differentiating benign amd malignant

adnexal lesions will be calculated.

19
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4. Harris RD, Javitt MC, Glanc P, Brown DL, Dubinsky T, Harisinghani MG,

Khati NJ, Kim YB, Mitchell DG, Pandharipande PV, Pannu HK. ACR

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5. Timmerman D, Ameye L, Fischerova D, Epstein E, Melis GB, Guerriero S,

Van Holsbeke C, Savelli L, Fruscio R, Lissoni AA, Testa AC. Simple

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14;341:c6839.

6. Ameye L, Timmermann D, Valentin L, Paladini D, Van Holsbeke C, Lissoni

AA, Savelli L,Veldman J,Testa AC,Amant F, Clinically oriented three-step

strategy for the assessment of adnexal pathology.Uitrasound in obstetrics &

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7. Andreotti RF, Timmerman D, Benacerraf BR, Bennett GL, Bourne T, Brown DL,

Coleman BG, Frates MC, Froyman W, Goldstein SR, Hamper UM, Horrow MM,

Hernanz-Schulman M, Reinhold C, Strachowski LM, Glanc P. Ovarian-Adnexal

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 Reporting Lexicon for Ultrasound: A White Paper of the ACR Ovarian-Adnexal

Reporting and Data System Committee. J Am Coll Radiol. 2018 Oct;15(10):1415-1429.

doi: 10.1016/j.jacr.2018.07.004. Epub 2018 Aug 24. Erratum in: J Am Coll Radiol. 2019

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8. Timor-Tritsch IE, Lerner JP, Monteagudo A, Santos R. Transvaginal

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directed Doppler measurements and a morphologic scoring system.

American journal of obstetrics and gynecology. 1993 Mar 1;168(3):909-13.

9. Solis Cano DG, Cervantes Flores HA, De Los Santos Farrera O, Guzman Martinez NB,

Soria Céspedes D. Sensitivity and Specificity of Ultrasonography Using Ovarian-

Adnexal Reporting and Data System Classification Versus Pathology Findings for

Ovarian Cancer. Cureus. 2021 Sep 1;13(9):e17646. doi: 10.7759/cureus.17646. PMID:

34650841; PMCID: PMC8489358.

10. Hack K, Gandhi N, Bouchard-Fortier G, Chawla TP, Ferguson SE, Li S, Kahn D, Tyrrell

PN, Glanc P. External Validation of O-RADS US Risk Stratification and Management

System. Radiology. 2022 Jul;304(1):114-120. doi: 10.1148/radiol.211868. Epub 2022

Apr 19. PMID: 35438559.

11. Cao L, Wei M, Liu Y, Fu J, Zhang H, Huang J, Pei X, Zhou J. Validation of American

College of Radiology Ovarian-Adnexal Reporting and Data System Ultrasound (O-

RADS US): Analysis on 1054 adnexal masses. Gynecol Oncol. 2021 Jul;162(1):107-112.

doi: 10.1016/j.ygyno.2021.04.031. Epub 2021 May 7. PMID: 33966893.

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12. Jha P, Gupta A, Baran TM, et al. Diagnostic Performance of the Ovarian-Adnexal

Reporting and Data System (O-RADS) Ultrasound Risk Score in Women in the United

States. JAMA Netw Open. 2022;5(6):e2216370.

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RADS, and ADNEX for Diagnosis of Adnexal Masses: An External Validation Study

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Ibrahim SA, Mohamed EA, Mohamed AEM, Afifi AHM, Harb OA, Algazzar HY.

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of the Ultrasound ADNEX Model for Benign and Malignant Ovarian Tumors. Int J Gen

Med. 2021; 14:5665-5673

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17. Huang X, Wang Z, Zhang M and Luo H (2021) Diagnostic Accuracy of the ADNEX

Model for Ovarian Cancer at the 15% Cut-Off Value: A Systematic Review and Meta-

Analysis. Front. Oncol. 11:684257.

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 ANNEXURE 1
UCMS & GTB HOSPITAL

UNIVERSITY OF DELHI, DELHI-110095

INFORMED CONSENT FORM

This Informed Consent Form is for the female patients who are referred from Department of
Obstetrics and Gynecology to the Department of Radio-Diagnosis for ultrasonography and whom
we are inviting to participate in research on evaluation pf adnexal masses by ORADS grading and
IOTA-ADNEX model and comparison with pathological diagnosis.
The title of our research project: ROLE OF OVARIAN ADNEXAL REPORTING DATA
SYSTEM (ORADS) FOR EVALUATION OF ADNEXAL PATHOLOGIES AND
COMPARISON WITH IOTA-ADNEX MODEL

Name of PG Student: Dr. Anju Chaudhary; Phone:9821855028

Name of Supervisor: Dr. Anupama Tandon
Name of Organization: University College of Medical Sciences and GTB Hospital, Dilshad
Garden, New Delhi – 110095.

This Informed Consent Form has two parts:

1. Information Sheet (to share information about the research with you)
2. Certificate of Consent (for signatures if you agree to take part)

You will be given a copy of the full Informed Consent Form

PART I: Information Sheet

Introduction: I am Dr. Anju Chaudhary working as a first year post graduate trainee in Dept. of
Radio-Diagnosis, University College of Medical Sciences and GTB Hospital. We are doing
research on role of ovarian adnexal reporting data system (ORADS) for evaluation of adnexal
pathologies and comparison with IOTA-ADNEX model and invite you to be a part of this.
There may be some words that you do not understand. Please ask me to stop as we go through the
information and I will take time to explain. If you have questions later, you can ask them.

Purpose of the research: Various models have been proposed for prediction of malignancy in
adnexal lesions. However, most of them lack standardization of terminology and definitions to
differentiate benign and malignant. The Ovarian-Adnexal Reporting and Data System (O-RADS)

24
ultrasound (US) risk stratification and management system was first published by the American
College of Radiology in 2020, providing standardized terminology for evaluation of ovarian and
adnexal masses, aiding risk stratification, and providing management guidelines for different
categories of lesions. Several retrospective studies have validated this system as an effective and
excellent diagnostic tool for predicting malignancy risk. However, prospective studies are scanty and
there is no Indian literature available.
Type of Research Intervention: The patients satisfying the selection criteria will first undergo
transvaginal ultrasonography complemented with transabdominal to study the morphological
features and graded on basis of ORADS and IOTA-ADNEX followed by histopathological
analysis of Adnexal lesion.
Participant selection: Female patients of all ages with clinical suspicion of adnexal lesion where
ultrasound detects an adnexal lesion, and Patients with adnexal lesions documented on previous
imaging

Voluntary Participation: The participation in this study is totally voluntary and you have the
right to opt out of the study at any point without giving any reason, and without penalty or loss of
routine care benefits.

Description of the Process: The patients will first undergo transvaginal and transabdominal
ultrasonography for adnexal lesions and based on ultrasonographic findings lesion will be graded
using ORADS and IOTA-ADNEX model and final result will be confirmed based on
histopathological diagnosis/ higher investigations/follow up scans.
Duration: The duration of this study will be from September 2022 to January 2024.

Side effects/risks/benefits/reimbursements: All aseptic precautions will be taken to minimize

chances of infection to minimum. We don’t have any policies for reimbursement.
Confidentiality: Confidentiality will be maintained about all the study subjects.

Sharing: An attempt will be made to share the findings of this research for general public and
scientific community through community meetings and publications. No confidential details will
be published without due permission.

Right to refuse: You don’t have to participate in this study to avail services of the Dept. of Radio-
diagnosis, GTB Hospital, the services will be available to you even if you choose not to participate
in this study.

Whom to Contact: In case of any queries you can contact me

Dr. Anju Chaudhary; Phone: 9821855028
This proposal has been reviewed and approved by Institutional Ethical Committee- Human
Research, University College of Medical Sciences, which is a committee whose task is to make
sure that research participants are protected from harm.
You can ask me any more questions about any part of the research study, if you wish to.

25
 PART 2: Certificate of Consent

I have read the foregoing information, or it has been read to me. I have had the opportunity to ask
questions about it and any questions that I have asked has been answered to my satisfaction. I
consent voluntarily to participate as a participant in this research.

Print Name of Participant __________________________________

Signature of Participant __________________________________
Date __________________________

If illiterate: I have witnessed the accurate reading of the consent form to the potential participant,
and the individual has had the opportunity to ask questions. I confirm that the individual has given
consent freely.

Print Name of witness _____________________ AND Thumb print of participant

Signature of witness _____________________________

Date ____________________________

Statement by the researcher/person taking consent

I have accurately read out the information sheet to the potential participant, and to the best of my
ability made sure that the participant understands that the following will be done:
The patients will first undergo transvaginal and transabdominal ultrasonography for adnexal
lesions and based on ultrasonographic findings lesion will be graded using ORADS and IOTA-
ADNEX model and final result will be confirmed based on histopathological diagnosis/ higher
investigations/follow up scans.
I confirm that the participant was given an opportunity to ask questions about the study, and all
the questions asked by the participant have been answered correctly and to the best of my ability.
I confirm that the individual has not been coerced into giving consent, and the consent has been
given freely and voluntarily.
A copy of this Informed Consent Form has been provided to the participant.

Print Name of Researcher___________________________________

Signature of Researcher ___________________________________

Date ___________________________

26
 यू सीएमएसऔरजीटीबीअस्पताल

दिल्लीदिश्वदिद्यालय, दिल्ली११००९५

ससससस ससससस ससससससस

यह सूचित सहमचत प्रपत्र उन मचहला रोचियोों के चलए है चिन्हें प्रसूचत और स्त्री रोि चिभाि से अल्ट्र ासोनोग्राफी

के चलए रे चियो-चनदान चिभाि में भे िा िाता है और चिन्हें हम ORADS ग्रेचिों ि और IOTA-ADNEX मॉिल

द्वारा मू ल्ाों कन पीएफ एिनेक्सल द्रव्यमान पर अनुसोंधान में भाि ले ने के चलए आमों चत्रत कर रहे हैं और

पैथोलॉचिकल चनदान के साथ तु लना कर रहे हैं ।

हमारी शोध पररयोजना का शीर्षक: ADNEXAL PATHOLOGIES के मूल्ाांकन और IOTA-ADNEX

मॉडल के साथ तु लना के दलए दडम्बग्रांदथ ADNEXAL ररपोदटिं ग डे टा दसस्टम (ORADS) की भूदमका

पीजीछात्रकानाम: डॉ. अंजु चौधरी; फोन: 9821855028

पयषवेक्षककानाम: डॉ. अनुपमा टं डन

संगठनकानाम: यूननवनसषटीकॉले जऑफमे नडकलसाइं सेजऔरजीटीबीअस्पताल,

निलशािगाडष न, नईनिल्ली - 110095

इस सूनचत सहमनत फॉमष के िो भाग हैं :-

1. सूचना प्रपत्र (अनुसंधान के बारे में आपके साथ जानकारी साझा करने के नलए)

2. सहमनत प्रमाण पत्र (हस्ताक्षर के नलए, यनि आप भाग ले ने के नलए सहमत हैं )

आपको पूणष सूनचत सहमनत फॉमष की एक प्रनत िी जाएगी।

27
 भाग I: सूचनापत्र

परिचय:मैं डॉ. अंजु चौधरी, रे नडयो-डायग्नोनसस नवभाग, यूननवनसषटी कॉले ज ऑफ मे नडकल साइं सेज और

जीटीबी अस्पताल में प्रथम वर्ष स्नातकोत्तर प्रनशक्षु के रूप में कायष कर रहा हं । ADNEXAL

PATHOLOGIES के मूल्ाांकन और IOTA-ADNEX मॉडल के साथ तु लना के दलए दडम्बग्रांदथ

ADNEXAL ररपोदटिं ग डे टा दसस्टम (ORADS) की भूदमकाI

आपको इसका नहस्सा बनने के नलए आमं नत्रत करते हैं।

कुछऐसेशब्दहोसकते हैंजोआपकोसमझमें नआएं ।कृपयामु झेरुकनेकेनलएकहें औरमैं उसकोसमझाऊंगा।यनि

आपकेपासबािमें प्रश्नहैं , तोआपउन्हें पूछसकते हैं।

अनु संधानकाउद्दे श्य: एएएएएएएए एएएएए एएए एएएएएएएए एए एएएएएएएएएए एए एएए एएएएएएए

एएएए एएएएएएएएएए एएए एए एएएए एएएएएएए, एएएएए एए एएएएएएए एएए एएएएए एए एएएए एए

एएए एएएए एए एएए एएएएएएएए एए एएएएएएएएए एए एएएएएएएए एए एएए एएए एएएएएएएएएएए-

एएएएएएएए एएएएएएएएएए एए एएएए एएएएएए (ए-एएएएएएए) एएएएएएएएएएएए (एएएए) एएएएए

एएएएएएएए एए एएएएएएए एएएएएएए एए एएएए एएए 2020 एएए एएएएएएए एएएएए एए

एएएएएएएएएए एएएएएए एएएएएएएए एएएए एएए एए, एए एएएएएएएएएएए एए एएएएएएएए एएएए

एए एएएएएएएएए एए एएए एएएएएएएए एएएएएएएए एएएएएए एएएए एए, एएएएए एएएएएएएए एएए

एएएएएए एएएए एए, एए एएएएए एए एएएएएएए एएएएएएएएए एए एएए एएएएएएए एएएएएएएएएएए

एएएएएए एएएए एएए एए एएएएएएएएएएए एएएएएएएए एए एए एएएएएएए एए एएएएएएएए एएएएए

एए एएएएएएएएएए एएएए एए एएए एए एएएएएएए एए एएएएएएएए एएएएएएए एएएएए एए एएए एएए

एएएएए एएएए एएए एएएएए, एएएए एएएएएए एएएए एए एएए एए एएए एएएएएए एएएएएएए एएएएएए

एएएए एएए

अनु संधान हस्तक्षे प का प्रकाि: ियन मानदों िोों को पूरा करने िाले रोचियोों को पहले रूपात्मक चिशेषताओों

का अध्ययन करने के चलए टर ाों सएब्िोचमनल के साथ पूरक टर ाों सिेिाइनल अल्ट्र ासोनोग्राफी से िुिरना होिा

28
और ORADS और IOTA-ADNEX के आधार पर ििीकृत चकया िाएिा, इसके बाद

चहस्टोपैथोलॉचिकलएिनेक्सल घाि का एक नैचलचसस होिा।

प्रतिभागी चयन: एिनेक्सल घाि के नैदाचनक सोंदेह के साथ सभी उम्र की मचहला रोचियोों िहाों अल्ट्र ासाउों ि

एक adnexal घाि का पता लिाता है, और adnexal घािोों के साथ रोचियोों को चपछले इमे चिोंि पर प्रले खित

स्वैच्छिक भागीदािी: इस अध्ययन में भागीिारी पूरी तरह से स्वै च्छिक है और आपको नबना नकसी कारण के

नकसी भी नबंिु पर अध्ययन से बाहर ननकलने का अनधकार है , और नबना अथष िं डयाननय नमत िे खभाल लाभ

के नुकसान के।

प्रतिया का तिििण: रोदगयोां को पहले adnexal घािोों के चलए transvaginal और transabdominal

ultrasonography से िुिरना होिा और ultrasonographic चनष्कषों के आधार पर घाि ORADS और IOTA-

ADNEX मॉिल का उपयोि कर ििीकृत चकया िाएिा और अोंचतम पररणाम चहस्टोपैथोलॉचिकल चनदान /

उच्च िाों ि / अनुिती स्कैन के आधार पर पुचि की िाएिी।

अितध: इस अध्ययन की अवनध नवंबर 2021 से अप्रैल 2024 तक होगी।

साइडइफेक्ट् स / जोच्छिम / लाभ / प्रतिपूतिि : सोंक्रमण की सोंभािना को कम से कम करने के चलए एक

एलएल एसेचिक सािधाचनयाों बरती िाएों िी। हमारे पास प्रनतपूनतष के नलए कोई नीनत नहीं है।

गोपनीयिा: सभी अध्ययन नवर्यों के बारे में गोपनीयता रखी जाएगी।

साझाकिण:सामु िानयक बैठकों और प्रकाशनों के माध्यम से आम जनता और वैज्ञाननक समु िाय के नलए इस

शोध के ननष्कर्ों को साझा करने का प्रयास नकया जाएगा। नबना अनुमनत के कोई भी गोपनीय नववरण

प्रकानशत नहीं नकया जाएगा।

29
मना किने का अतधकाि: रे नडयो-ननिान, जीटीबी अस्पताल के नवभाग की सेवाओं का लाभ उठाने के नलए

आपको इस अध्ययन में भाग ले ने की आवश्यकता नहीं है , यनि आप इस अध्ययन में भाग नहीं ले ना चाहते हैं

तो भी सेवाएं आपके नलए उपलब्ध होंगी।

तकस से संपकि किें : नकसी भी प्रश्न के मामले में आप मुझसे संपकष कर सकते हैं

डॉ. अंजु चौधरी; फोन: 9821855028

इस प्रस्ताव की समीक्षा की गई है और संस्थागत नैनतक सनमनत- मानव अनुसंधान, यूननवनसषटी कॉले ज ऑफ

मे नडकल साइं सेज द्वारा अनुमोनित है , जो एक सनमनत है नजसका कायष यह सुनननित करना है नक अनुसंधान

प्रनतभानगयों को नुकसान से बचाया जाए।

यनि आप चाहें , तो आप मु झे शोध अध्ययन के नकसी भी भाग के बारे में कोई भी प्रश्न पूछ सकते हैं ।

30
 भाग 2: सहमतिकाप्रमाणपत्र

मैं ने पूवष गामी जानकारी पढी है , या इसे मु झे पढकर सुनाया गया है । मु झे इसके बारे में प्रश्न पूछने काअवसर

नमला है और जो भी प्रश्न मैं ने पूछे हैं उनका उत्तर मे री संतुनि के नलए निया गया है । मैं स्वे िा से इस शोध में

एक भागीिार के रूप में भाग ले ने के नलए सहमनत िे ता/िे ती हं ।

प्रनतभागी का नप्रंट नाम __________________________________

प्रनतभागी का हस्ताक्षर __________________________________

निनां क __________________________

यतद अतितक्षि हैं :

मैं ने संभानवत प्रनतभागी को सहमनत फॉमष का सटीक वाचन िे खा है , और व्यच्छि को प्रश्न पूछने का अवसर

नमला है । मैं पुनि करता/करती हं नक व्यच्छि ने स्वतं त्र रूप से सहमनत िी है ।

गवाह का नाम _____________________ और प्रनतभागी का अंगूठा का ननशान

गवाह के हस्ताक्षर _____________________________

निनां क ____________________________

सहमनत ले ने वाले शोधकताष / व्यच्छि का कथन

मैं ने संभानवत प्रनत भागी को सूचना प्रपत्र को सटीक रूप से पढा है , और मे री सवोत्तम क्षमता को सुनननित

नकया है नक प्रनतभागी समझता है नक ननम्न नलच्छखत नकया जाएगा:

31
रोदगयोां को पहले adnexal घािोों के चलए transvaginal और transabdominal ultrasonography से िुिरना

होिा और ultrasonographic चनष्कषों के आधार पर घाि ORADS और IOTA-ADNEX मॉिल का उपयोि

कर ििीकृत चकया िाएिा और अोंचतम पररणाम चहस्टोपै थोलॉचिकल चनदान / उच्च िाों ि / अनुिती स्कैन के

आधार पर पुचि की िाएिी।

मैं इस बात की पुनि करता/करती हं नक प्रनतभागी को अध्ययन के बारे में प्रश्न पूछने का अवसर निया गया

था, और प्रनतभागी द्वारा पूछे गए सभी प्रश्नों का सही और मे री सवषश्रेष्ठ क्षमता के नलए उत्तर निया गया है। मैं

इस बात की पुनि करता/करती हं नक व्यच्छि को सहमनत िे ने के नलए बाध्य नहीं नकया गया है, और सहमनत

स्वतं त्र रूप से और स्वे िा से िी गई है ।

इस सूनचत सहमनत फॉमष की एक प्रनतप्रनत भागी को प्रिान की गई है ।

शोधकताष का नप्रंट नाम ___________________________________

शोधकताष का हस्ताक्षर ___________________________________

निनां क __________________________

32
 ANNEXURE 2
PATIENT PERFORMA
Name: Age/Sex:

Date of study: Address;

C.R.No.: Occupation:

Presenting complaints:

Pain abdomen

Abdominal mass:

Abdominal distention:

Menstrual irregularity:

Discharge per vaginum:

History of similar complaints in the past:

LMP:

Menstrual history:

History of amenorrhoea / oligomenorrhoea / dysmenorrhoea/ menorrhagia /

metrorrhagia /dyspareunia:

History of bleeding/discharge PV:

Obstetric history:

History of weight loss:

Relevant family history:

Other relevant history:

33
 EXAMINATION

GENERAL EXAMINATION:
Pulse........... BP..........

Temp........... RR..........

GENERAL PHYSICAL EXAMINATION

Conscious/cooperative/oriented

Pallor........... Icterus........... Cyanosis...........

Clubbing........... Lymph nodes........... Pedal edema...........

Weight........... Height...........

SYSTEMIC EXAMINATION:
Per abdomen examination: lump/mass size, unilateral or bilateral, location, nature

surface, contour, evidence of free fluid.

P/V findings:

P/S findings :

CVS:

RS:

34
CNS:

LABORATORY INVESTIGATION (including complete hemogram, urine pregnancy

test, tumour markers and other biochemical investigations wherever it is applicable)

CLINICAL DIAGNOSIS:
IMAGING FINDINGS: Characterization of lesions

 Location-

 Bilaterality

 Maximum diameter of the lesion-

 Solid/cystic-

1. If cystic lesion- unilocular/multilocular

a. If unilocular assess- Inner wall-smooth/irregular

Internal echoes/septa

Size of lesion-

Size of irregularities of inner wall-

No. of Papillary projections-

b. If multilocular assess- Size of lesion-

contour of inner wall/septa-

Presence/absence of solid component-

Color flow scoring-

2. If solid lesion- outer contour-

35
 Color flow scoring-

 Acoustic shadows

 Ascites

 CA-125 value-

ANY OTHER RADIOLOGICAL INVESTIGATION (if any):

RADIOLOGICAL DIAGNOSIS:

MEDICAL TREATMENT (if any):

SURGICAL TREATMENT (if

any): FOLLOW UP:

Pathological Evaluation (wherever possible):

a. FNAC/FNAB

b. Histopathology

36