Accuracy Of Sonography In Comparison With Histopathology In

Characterization Of Thyroid Nodule For Differentiating Bengin

From Malignant Nodule.

Research proposal
2022
Supervisor
Dr.Mahmoud Alhadad Dr.khaled aljamrh

Prepared by : - Group (C6b)

Ali Abdu Alsaeedi, Basheer Alzakari, Abeer Ghailan, Adel Ghailan,Omima Talal ,
Somaiah Al khobani ,Omima Alamari, Amar Hassan, Mohammed Alomari,Hani
Althobaibi ,Mohamed Khaled ,Nasr Algeradi.

Radiology department

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Table of Contents
content……………………………………………………………………………..……………………………………………2
Introduction:- .................................................................................................................................. 3
Objective:- ....................................................................................................................................... 3
literature Reviews ........................................................................................................................... 3
Materials and Methods .................................................................................................................. 5
Overview ...................................................................................................................................... 5
Study population ......................................................................................................................... 5
Data collection and management ............................................................................................... 5
US Image analysis ........................................................................................................................ 5
Data analysis ................................................................................................................................ 6
Ethical consideration....................................................................................................................... 6
Budget: ............................................................................................................................................ 7
EXPECTED OUTCOME ...................................................................................................................... 7
ANNEXES.(workplane) .................................................................................................................... 8
Questionnaire………………………………………………………………………………………………………………………….9
REFERENCES:- ................................................................................................................................ 11

2
Introduction:-
Thyroid nodules are very common medical problem in general population.[1,2] The
prevalence of thyroid nodularity varies from 19% to 67%, and increases with age, affecting
about 50% of the population older than 40 years of age (3-7).About 7% to 15% of thyroid
nodules are thyroid cancer, it was estimated that 96% of all new endocrine organ cancers
originate from the thyroid gland in 2014.[8-9]which is much higher than the incidence of
other head and neck tumors. In recent years, the incidence of thyroid cancer has
increased year by year; now it is the fifth most common cancer diagnosed in females, and
it is expected to become the second most common malignancy in females and the ninth
most common malignancy in males by the year 2030 (10). it is important to diagnose
early because thyroid cancers progress slowly and a long survival is possible with early
treatment (11-12)
Current thyroid guideline recommendations call for imaging modalities to detection of
thyroid malignancies early leading to a better prognosis [13].
Ultrasound scanning is widely cited as the imaging modality of choice for early diagnosis
Because it is a valuable, safe, nonionizing, cost effective, widely available, and easily
reproducible imaging tool for diagnosis of clinically suspected thyroid(14)
.Despite the highlighted advantages in ultrasound imaging, evidence is not conclusive in
predicting thyroid malignancies [15-16]. Hence, the diagnostic accuracy of the ultrasound
scanning needs to be evaluated by comparing with the results of a gold standard test .Fine
needle aspiration cytology (FNAC) is considered as the most reliable cost effective method
for definitive evaluation of thyroid nodules [17-18]. thyroid cancer management
guidelines recommend conducting FNAC on any thyroid nodule, which is suspected to be
malignant (7-19-20).

Objective:-
This study is aim for determining the diagnostic accuracy of the ultrasound
characteristics in the identification of benign from malignant thyroid nodules

literature Reviews
- There are studies conducted as in Japan from the noguchi thyroid clinic and
hospital Fourdation Oita on 2001 about ultrasonographic characteristics of
thyroid nodules (21).They created a formula for predicting malignancy of thyroid
nodules on the basis of multiple logistic regression analysis with the use of only 5

3
US features. It can be applied to non follicular thyroid neoplasm with high
accuracy but not to follicular thyroid .
- Also there is study in Korea in department of radiology , Kangbuk Samsung
Hospital , Sungkyunkwan University School of Medicine Seoul on 2008 about
benign and malignant thyroid nodules : US differentiation - multicenter
retrosepetive study (22). They proved the diagnostic accuracy of US criteria is
dependent on tumor size which Statistically significant (P<.05) findings of
malignancy were a taller-than-wide shape (sensitivity, 40.0%; specificity, 91.4%),
a spiculated margin (sensitivity, 48.3%; specificity, 91.8%), marked
hypoechogenicity (sensitivity, 41.4%; specificity, 92.2%), micro calcification
(sensitivity, 44.2%; specificity, 90.8%), and macro calcification (sensitivity, 9.7%;
specificity, 96.1%). The US findings for benign nodules were isoechogenicity
(sensitivity, 56.6%; specificity, 88.1%; P<.001) and a spongiform appearance
(sensitivity, 10.4%; specificity, 99.7%;
P<.001). The presence of at least one malignant US finding had a sensitivity of
83.3%, a specificity of 74.0%, and a diagnostic accuracy of 78.0%. For thyroid
nodules with a diameter of 1 cm or less, the sensitivity of microcalcifications was
lower than that in larger nodules (36.6% vs 51.4%, P<.05).

- In Karachi Pakistan in department of radiology , the Age Khan University Hospital

on 2014 ,about diagnosis accuracy of ultrasonography in differentiating benign
and malignant thyroid nodules using fine needle aspiration cytology as the
reference standard(23). They conclcuded that the US have a high diagnostic
accuracy in detecting malignancy in thyroid nodules on basis of features like
echogenicity, margins, micro calcifcations and shape. Radiologists’ must be
familiar with these signs on ultrasound that aid to distinguish benign from
malignant thyroid nodules and thus avoiding unnecessary FNAC.
- In Alexandria , Egypt in department of ororhinolaryngology - head and neck
surgery , faculty of medicine , Alexandria University on 2020 about the diagnosis
value of ultrasonography in detection of different types of thyroid nodules(24).
The proved that the
Ultrasonography is a very essential sensitive tool in detection of thyroid nodule
type, especially if it is done by well-experienced radiologist. The sensitivity of
ultrasound in detecting different types of thyroid nodules was 100.0%, with
specificity 94.12% and accuracy 96.0%

4
Materials and Methods
Overview
A cross-sectional analytical study is designed to be retrospectively collect data from the
department of Radiology and histopathology center in Hospital of sana'a city in the time
period of 2021-2022 .

Study population
Patients of either gender presenting with palpable thyroid nodule (diagnosed by primary
physician on clinical examination) referred to Radiology department for thyroid
ultrasound followed by fine-needle aspiration cytology or histopathology of thyroid
nodules will included after an informed consent

Data collection and management: The sources of data for this study are health
facility registers, patient fills,. First data collection tool will be developed for data
collection from facility registers and patient fills and for the interview. Then training
manual and trainer guide will be developed for data collectors. Training will be given to
data collectors and their supervisors on the data collection tools, ethical issues, data
quality assurance, inter-personal communication skills and how to handle challenges
that may appear in data collection process and team work. After the training the data
collectors will test the data collection tools (from registers and interview).

The supervisors will oversee the data collection process in both the pretesting and
actual data collection time. They also give on-the-spot corrections and feedback for the
data collectors to ensure the quality of the data. They also collect the filled checklists on
daily basis and check for its completeness, consistency, and quality

US Image analysis
A thyroid nodule will be considered positive on Ultrasonography (US) or malignant if one
or more than one of following sonographic features are found:
microcalcification defined as punctuate (less than 2mm)
hyper echoic foci either with or without acoustic shadows

Micro-lobulation characterized as presence of many small lobules on surface of a nodule or

irregular margins( 25)

5
Marked hypoechogenicity demarcated as decreased echogenicity compared with surrounding
neck muscle

Shape characterized as shape of nodule taller than wider( 25)

Thyroid nodule is categorized as negative, that is, malignancy not found if none of the above
sonographer feature is seen.

A thyroid nodule is considered True positive (TP), i.e. malignancy detected, when specimen
showe cytological atypical cells (nuclei crowded and overlapping, enlarged and pleomorphic and
a thyroid nodule is considered True negative (TN)., that is, malignancy not established, when
specimen did not exhibit cytological atypical cells (nuclei crowded and overlapping, enlarged
and pleomorphic.(26)

A thyroid nodule considered false positive (FP) when ultrasound findings are suggestive of
malignancy(.27)
however specimen do not show cytological atypical cells. Similarly a thyroid nodule is considered
false negative (FN), when it is reported as benign on ultrasound findings

Positive predictive values (PPV) are calculate to determine the probability of a patient having
thyroid malignancy when the nodule is reporte as malignant on ultrasonography. Similarly
negative predictive values (NPV) are calculated to find the proportion of patients, not having
malignancy amongst all those which are reporte as having benign on ultrasonography.

Diagnostic accuracy will be calculated to express the proportion of correctly classified

subjects (Patients having thyroid malignancy+patients with benign thyroid nodules, TP+TN)
among all subjects (TP+TN+FP+FN).

Nodule size is not included in the criteria as it is not predictive of malignancy, because the
likelihood of cancer in a thyroid nodule has been shown to be the same regardless of the size
measured at US.( 28)

Data analysis
Data will entere and analyze in SPSS. Descriptive analyses will compute frequencies and
percentages for categorical variables like sex, malignancy in thyroid nodules. Sensitivity,
Specificity, Positive predictive value (PPV), Negative predictive value (NPV) will computed. In
addition, diagnostic accuracy will also reporte of each feature. Diagnostic accuracy of ultrasound
in detection of malignancy in thyroid nodules will be also calculated with FNAC or histopatholgy
as reference. Likelihood ratios well be also computed and reported.

Ethical consideration
 Approval to conduct the study will be obtained from the state and local
government ethics committee
6
  Ethics in clinical research involves a set of relevant rules considered in the contact
of clinicalstudy

 The ethical conduct of a clinical research does not end with the formulation of the
study design and a signature on the informed consent form

 Protecting the rights, interests, and safety of research subjects must continue
throughout the study duration.

 Subject safety monitoring is the responsibility of several groups, including IRBs,

investigators and their research staffs, sponsors, and data monitoring committees
(DMCs).
 An informed consent is a voluntary agreement to participate in a clinical research
study. It is not merely a form that.

 Respect for Persons: The principle of respect requires that subjects participating
in the research should be fully aware of the natural of such research and assured
that such participation is voluntary, with no pressure or druss.

 They should also be aware of the physical, psychological, and socio-economic risks
that such participation might bring to the subject immediately or in the future.

 Respect for the dignity of research participants should be prioritized .

 Adequate level of confidentiality of the research data should be ensured.

Budget:
We need to carry out the study some of investigations to the the patient that come to
the hospital complaining of thyroid swelling in form of sonography.also we need to
confirm the result of sonography by thyroid gland biopsy..also we need to carry out the
research transportation cost.

EXPECTED OUTCOME
 Determine the ability of US to differentiate between benign and malignant thyroid
nodule.
 From this study we can determine number of cases that benefit from use
ultrasonography.
 From this study we can tell patient about the benefit of ultrasonography for determine
the main diagnosis without side effect .
 From this study we can Know the need of histopathology to confirm the US results.

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 ANNEXES.(workplane)
2022 2023

March April May Jun July Agus Spe Oct Nov Dec Jua
Activity
1. Finalize the
research proposal

2. Finalize
questionnaire and
checklists
3. Secure budget

4. Earn ethical
clearance
5. Training of data
collectors

6. Pilot study and

revision of the
instrument
7. Data collection

8. Data entry and

data cleaning
9. Data analysis
and produce
draft research
paper
10. Share the
research paper
for input

11. Incorporate
comments
and finalize the
research project
12. Submit the
research paper for
publication in
peer reviewed
journal

8
 (Questionnaire)

Incidence of benign and malignant tumor in patient with thyroid

nodules
Personal Data:
Name:- ……………………………………………. Age :-……………. Sex:- Female ( ) . Male ( ).
Marital state :- Single ( ) . Married ( ) .Absolute ( ) .Widowed ( ) .

Place & Address ………………………..………………….. Occupation ………………………………………………….

Habit :- Qat chewing ( ) . Smoking ( ) . Shmma use ( ) . other ………….…….... ….

Hospital :- Althawra ( ). Algomhori ( ). Alkwite ( ). Other ……………………………………

Ultrasonography finding:-
Number of nodule : Absent ( ). Single ( ). Multi ( ).

Nodule types: Smooth ( ). Solid ( ). Partially cystic ( ). Cystic .( ) Mixed ( ) .

Echogenicity status : Anechoic. ( ). Hypoechogenicity ( ). Hyperechogenicity.( ).

Isoechogenicity. ( ). Hypoisoechogenicity. ( ).

- Nodule edge status : Regular. ( ). Irregular. ( ). Microlobulated. ( )Infiltrative ( ) .

- Nodule Size : Normal size( ) . Smaller than 1cm ) (. Larger than 1cm( ).
- Nodule shape : Normal( ). Round( ). Oval( ). Wider than taller( )
Taller than wider( ) . Smaller than wider( ).
Calcification: Absent( ). Microcalcification ( ). Macrocalcification ( ). -
Cervical lymph node: Normal( ). Enlarged( ). -

-Vascularity : Absent. ( ) . Central vascularity ( ) . Peripheral vascularity. ( )

.Mixed. ( ) .

Invasion : Absent( ). Present( ). --

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Clinical Features :-
……………………………………………………………………………………………………………….......
..........................................................................................................................

Histopathology Finding
- Insufficient cellularity ( ). Obscuring blood ( ).

- Macrofollicles ( ). Microfollicles ( ).

- Abundant colloid ( ) Sparely cellular ( ).

- Mild nuclear changes ( ). Hypercellular . ( ).

- Crowdin ( ). Scant colloid. ( ).

- Papillary clusters. ( ). Follicular clusters. ( ).

- Definitive nuclear changes ( ). Psammoma body ( ).

- Nuclear atypia. ( ). Cell hyperplasia ( ).

- Cystic degeneration ( ). Cellular hemorrhage ( ).

- Cellular fibrosis ( ). Cellular necrosis ( ).

- Capsular invasion ( ). Vascular invasion ( ).

- Nuclear clearing ( ). Nuclear groove . ( ).

- Scattered groups ( ). Hyperchromatic cells ( ).

- Polymorphic Cells ( ).

Note:…………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
Student Name:
…………………………
…………………………

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