TIRADS

1. EVALUATION OF THYROID NODULES USING
THYROID IMAGING REPORTING AND DATA
SYSTEM(TIRADS)AND ITS HISTOPATHOLOGICAL
CORRELATION.
DR. SAHANA.S
REG. NO: 1601201002 | JUNE/2016 | JUNE/2019
MD., RADIODIANOSIS, MGMCRI
GUIDE
DR. RAMALINGAM.A
PROFESSOR
DEPARTMENT OF RADIODIAGNOSIS, MGMCRI
Co-GUIDE
DR. UDHAYAKUMAR.K
A SSIST A N T PROFESSOR
DEPARTMENT OF RADIODIAGNOSIS, MGMCRI
Co-GUIDE
DR. K.V. RAJAN
A SSOCIA T E PROFESSOR
DEPARTMENT OF GENERAL SURGERY
MAHATMA GANDHI MEDICAL COLLEGE & RESEARCH INSTITUTE

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CANDIDATE
 Candidate Name : SAHANA.S
 Course of Study : MD RADIODIAGNOSIS
 University Identity No : 1601201002
 Mobile Phone No : +919940072500
 E-mail Address :sahanasubramani@gmail.com
 Month/Yr of Admission : JUNE 2016
 Month/Yr of Examination : JUNE 2019
GUIDES
 GUIDE: DR. RAMALINGAM.A
 Professor
 Department of Radio diagnosis
 9094823673
 dr_ar_asa@yahoo.com
Click here to enter text.
 CO GUIDE: DR. UDHAYAKUMAR.K
 Assistant Professor
 Department of Radio diagnosis
 9952232833
 drudhay13@gmail.com
 CO GUIDE: DR. K.V.RAJAN
 Associate Professor
 Department of General Surgery
9791353360
 57sylvan@gmail.com

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PART II – THE PROTOCOL
1 INTRODUCTION
The THYROID GLAND is an endocrine organ in the neck which is completely
enveloped by the middle-layer of the deep cervical fascia and lies in the visceral
space.
The thyroid extends from C5 to T1 and lies anterior to the thyroid and cartilages of
the larynx and the first three tracheal rings.
The thyroid is butterfly or "H"-shaped and is composed of two lobes, each with a
superior and inferior pole, connected by an isthmus. Each lobe measures
approximately 4 cm in length.
The parathyroid glands lie posteromedially and are sometimes intracapsular (1).
EMBRYOLOGY
The thyroid gland is the first of the body's endocrine glands to develop, on
approximately the 24th day of gestation. The thyroid originates from two main
structures: the primitive pharynx and the neural crest. The rudimentary lateral thyroid
develops from neural crest cells, while the median thyroid, which forms the bulk of
the gland, arises from the primitive pharynx. The thyroid gland forms as a
proliferation of endodermal epithelial cells on the median surface of the developing
pharyngeal floor. The site of this development lies between 2 key structures, the
tuberculum impar and the copula, and is known as the foramen cecum. The thyroid
initially arises caudal to the tuberculum impar, which is also known as the median
tongue bud. This embryonic swelling develops from the first pharyngeal arch and
occurs midline on the floor of the developing pharynx, eventually helping form the
tongue as the two lateral lingual swellings overgrow it.
The thyroid gland forms as a proliferation of endodermal epithelial cells on the
median surface of the developing pharyngeal floor. The site of this development lies
between 2 key structures, the tuberculum impar and the copula, and is known as the
foramen cecum. The thyroid initially arises caudal to the tuberculum impar, which is
also known as the median tongue bud. This embryonic swelling develops from the
first pharyngeal arch and occurs midline on the floor of the developing pharynx,
eventually helping form the tongue as the two lateral lingual swellings overgrow it.
ANATOMY
anteriorly: strap muscles
posteriorly: thyroid cartilage, cricoid cartilage, trachea
posteromedially: tracheo-oesophageal groove (containing lymph nodes, recurrent
laryngeal nerve, parathyroid glands)

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posterolaterally: carotid space
ARTERIAL SUPPLY
superior thyroid artery (from external carotid artery)
inferior thyroid artery (from thyrocervical trunk)
if the inferior thyroid artery arises from the subclavian artery it is referred to as
an accessory inferior thyroid artery
VENOUS DRAINAGE
superior thyroid vein (drains to internal jugular vein)
middle thyroid vein (drains to internal jugular vein)
inferior thyroid vein (drains to brachiocephalic vein)
EPIDEMOLOGY
The ultrasound grading of the thyroid nodules is done by TIRADS. TIRADS is a risk
stratification system for classifying thyroid lesions. Its use is being advocated similar
to BIRADS category for breast lesions (3). A palpable thyroid swelling is a common
disorder and almost 12% of adult Asian Indians have been shown to have a palpable
nodule in a recent population‑based study. [1] When patients were assessed by
ultrasound, the prevalence of a thyroid nodule was as high as 80% among children in
iodine‑deficient parts of India. [2] However, the incidence of thyroid cancer is low
(1‑1.8 per 100,000). [3] Ultrasound is a widely accepted imaging modality for the
initial assessment of thyroid nodules
ON ULTRASOUND, Normal thyroid gland has an homogenous appearance, the
capsule may appear as a thin hyperechoic line (2)
each lobe normally measures
length: 4-6cm.
depth: <2 cm
isthmus measures <0.5 cm deep
2 AIMS AND OBJECTIVES
AIM: -To evaluate thyroid nodules using thyroid imaging reporting and
data system(TIRADS) and its histopathological correlation.

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OBJECTIVES:
a. To evaluate palpable thyroid nodules using ultrasound and grading the
nodule using TIRADS
b. To compare the TIRADS grading with FNAC and histopathology.
3 REVIEW OF LITERATURE
To develop a system which was very helpful for classifying thyroid lesions using
thyroid imaging reporting and data system (TIRADS) with which to categorize
thyroid nodules and stratify their malignant risk. US features showed a significant
association with malignancy: component of the nodule, hypo echogenicity, marked
hypo echogenicity, micro lobulated or irregular margins, micro calcifications, and
taller-than-wide shape. As the number of suspicious US features increased, the fitted
probability and risk of malignancy also increased (4).
CLASSIFICATION
Classification system has been proposed by Horvath et al (1), with a modified
recommendation from Jin Kwak et al (2).
Similar to BIRADS category, sonographic TIRADS classification is as follows
TIRADS 1: normal thyroid gland
TIRADS 2: benign lesions
TIRADS 3: probably benign lesions
TIRADS 4: suspicious lesions (sub classified as 4a, 4b, and later 4c 2 with increasing
risk of malignancy)
TIRADS 5: probably malignant lesions (more than 80% risk of malignancy)
TIRADS 6: biopsy proven malignancy
TIRADS 2 category
Avascular anechoic lesion with echogenic specks (colloid type I)
Vascular heteroechoic non-expansile, non-encapsulated nodules with peripheral halo
(colloid type II)
Isoechoic or heteroechoic, non-encapsulated, expansile vascular nodules (colloid
type III)
These conditions have 0% risk of malignancy.

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TIRADS 3 category
Hyperechoic, iso-echoic or hypoechoic nodules, with partially formed capsule and
peripheral vascularity, usually in setting of Hashimoto's thyroiditis (Hashimoto's
pseudonodule)
Modified TIRADS classification 2 have simplified TIRADS 3 category as none of
the suspicious malignant sonographic features described below. These lesions are
mostly benign with <5% risk of malignancy 1.
TIRADS 4 and 5 categories
These categories are based on five suspicious sonographic features of malignancy:
solid component
high stiffness of nodule on elastography if available
markedly hypoechoic nodule
microlobulations or irregular margins
micro calcifications
taller-than-wider shape
Subclassificaiton
TIRADS 4a: one suspicious feature
TIRADS 4b: two suspicious features
TIRADS 4c: three/four suspicious features
TIRADS 5: all five suspicious features
TIRADS 4a has 5-10% risk of malignancy, 4b and 4c may have 10-80% risk of
malignancy. TIRADS 5 category lesion have >80% risk of malignancy 1.
4 RESEARCH QUESTION OR HYPOTHESIS
How reliable is thyroid imaging reporting and data system(TIRADS) in identifying
the nature of thyroid nodules as diagnosed with FNAC and histopathology?

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5 SUBJECTS AND METHODS
5.1 STUDY SUBJECTS
The Study Involves HUMANS
5.2 TYPE OF STUDY
Cross sectional comparison study with prospective recruitment of patients.
5.3 PLACE OF STUDY
Department of Radiology, Mahatma Gandhi Medical College & Research Institute,
Pondicherry
5.4 SELECTION PROCESS
5.4.1 STUDY POPULATION
Patients with suspected thyroid nodule who are referred to the department of
Radio diagnosis, MGMCRI for Ultrasound of thyroid with FNAC / HPE correlation.
5.4.2 VOLUNTEERS RECRUITEMENT PROCESS
NIL
5.4.3 INCLUSION CRITERIA
 Patients referred with suspected thyroid nodule from General Surgery
Department, MGMCRI.
 Patients referred for ultrasound Thyroid who has thyroid nodules.

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 Patients who are willing to undergo resection and Fine needle aspiration
cytology of the thyroid nodule with a valid histopathology report.
5.4.4 EXCLUSION CRITERIA
 Patient who do not undergo Surgical excision or if the sample is
inadequate for FNAC.
 Nodules less than 10mm
 Patients undergoing chemotherapy and radiotherapy
 Pregnant or Lactating Women
 Patient who are not willing to participate in the study
5.4.5 SAMPLING PROCEDURE
All the patients with thyroid nodules who undergo surgical excision or FNAC during
the study period.
5.4.6 STUDY GROUPS
The Number of Groups is: 1
Patients with thyroid nodules who undergo FNAC or surgical resection in MGMC &
RI
5.4.7 SAMPLE SIZE

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All the patients with thyroid nodules who undergo surgical excision/FNAC during
the study period which comes around 50 based on the previous hospital records.
5.5 METHODOLOGY / PROCEDURES:
Patients who are referred to ultrasound of thyroid gland from general surgery out-
patient department. Ultrasound of Thyroid gland will be done on Siemens ACUSON
S2000 machine and MINDRAY DC-8 equipped with a 7.5–12 MHz high‑frequency
linear array transducer with color and power Doppler capability. Thyroid Nodules
will be graded using TIRADS classification system based on sonography features.
HPE/FNAC will be done for the nodule. Comparison of TIRADS with
Histopathology report in malignancy risk stratification.

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5.5.1 INTERVENTIONS/DRUGS USED
Nil
PATIENTS REFERRED FOR
ULTRASOUND OF THOID NODULE
(n= 50)
Excluded
 Not meeting inclusion criteria
 Declined to participate
 Other reasons
OUTCOME ANALYSIS OF TIRADS
AND HISTOPSTHOLOGICAL
CORRELATION FOR THYROID
NODULES
GRADING USING TIRADS
HISTOPATHOLOGICAL FINDINGS
GRADING
COMPARISON
AND ANALYSIS
ULTRASOUND OF
THYROID NODULE
ENROLLMENT
FNAC

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5.5.2 PROCUREMENT OF INVESTIGATIONAL DRUGS,
STORAGE, DISPENSING, ETC.
Nil
5.6 STUDY TERMINATION
Study will terminate once the study period is over.
6 STUDY VARIABLES
Distinguish between:
1. Ultrasound grading using TIRADS
2. FNAC report
3. Histopathological report
S. No
Name of the dependent /
independent variables
Scale of measurement
(Quantitative /
qualitative)
Descriptive / Inferential
Statistics to be used
1 Ultrasound grading using
TIRADS
Qualitative Chi-Square test
2 FNAC report Qualitative Chi-Square test
3 Histopathological report Qualitative Chi-Square test
6.1 DATA COLLECTION
Data will be collected using predefined data capture form / schedule / questionnaire.
Secondary Data will be collected from hospital records, ultrasound report and
histopathological report. Privacy and Confidentiality to be maintained. All patient
identifiable numbers and information should be stripped and replaced by anonymous
numbers.

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6.2 STATISTICAL METHODS
Data’s compared using Chi-square test
7 REFERENCES
1. Tan GH, Gharib H. Thyroid incidentalomas: management approaches to
nonpalpable nodules discovered incidentally on thyroid imaging. Ann Intern
Med 1997;126(3):226–231.
2. Kwak JY, Han KH, Yoon JH, et al. Thyroid imaging reporting and data
system for US features of nodules: a step in establishing better stratification
of cancer risk. Radiology2011;260(3):892–899.
3. Cooper DS, Doherty GM, Haugen BR, et al. Management guidelines for
patients with thyroid nodules and differentiated thyroid cancer. Thyroid
2006;16(2):109–142.
4. Park JY, Lee HJ, Jang HW, et al. A proposal for a thyroid imaging reporting
and data system for ultrasound features of thyroid carcinoma. Thyroid
2009;19(11):1257–1264.
5. Moon HJ, Kim EK, Kwak JY. Malignancy risk stratification in thyroid
nodules with benign results on cytology: combination of thyroid imaging
reporting and data system and Bethesda system. Ann Surg Oncol
2014;21(6):1898–1903.

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8 PRELIMINARY WORK DONE ALREADY
NIL
9 ETHICAL ISSUES
The Study Involves:
1. Young Subjects under the age of 18
2. Young Subjects studied in a School or Institutional Setting
3. Patients of Geriatric Age Group
4. Physical pain, beyond mild discomfort
5. Any perceived, possible or actual conflicts of interest. If you have
answered YES to any one or more of the above questions, replace all
questions above and enter the Issue below
The Study Involves Issue No:
Other Ethical Issues: If the Study is foreseen to have any other ethical issue than the
above mentioned, please include it here
Note: In India, ‘majority’ is achieved at an age of 18 years and considered a legal age
for giving a valid consent for treatment as per Indian Majority Act, Guardian and
Wards Act, and Indian Contract Act. A child below 12 years (minor) cannot give
consent, and parents/guardian can consent for their medical/surgical procedures. A
child between 12-18 years can give consent only for medical examination but not for
any procedure.
If you have any subject below the age of 18 or unable to give fully informed
independent consent, give details below:

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10 INFORMED CONSENT PROCEDURE
INFORMATION SHEET FOR THOSE WHO PLAN TO PARTICIPATE IN
THE RESEARCH PROJECT
NAME OF THE RESEARCH PROJECT: EVALUATION OF THYROID
NODULES USING THYROID IMAGING REPORTING AND DATA
SYSTEM(TIRADS) AND ITS HISTOPATHOLOGICAL CORRELATION
We welcome you and thank you for having accepted our
request to consider whether you can participate in our study. This sheet contains the
details of the study; the possible risks, discomfort and benefits for the participants are
also given.
You can read and understand by yourself; if you wish, we are ready to read and
explain the same to you.
If you do not understand anything or if you want any more details, we are ready to
provide the details.
Information to the participants:
What is the purpose of the study?
The purpose of the study is to compare between Thyroid Imaging Reporting and
Data System (TIRADS) of thyroid nodules with histopathological correlation
Who / where this study is being conducted?
This study is being conducted by Dr. Sahana.S Post
Graduate medical student belonging to Radiology department under the guidance of
Professor, Dr. Ramalingam.A and Assistant Professor, Dr. Udhayakumar.K
Why I am being considered as one of the participant?
Since you have been diagnosed to have Thyroid nodule and you have been
referred here for an ultrasound and to be a part of clinical management protocol.
Should I definitely have to take part in this study?

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No. If you do not wish to participate you will not be included in this study.
Also you will continue to get the medical treatment without any prejudice.
If I am participating in this study, what are my responsibilities?
You should understand the details of this study and give your written consent,
you should allow us to review your medical records
Are there any benefits for me / public?
Yes, you get benefitted by this and it helps in diagnosis and
management of your disease.
Will there be any discomfort / risks to me?
No risks. But some discomforts may be there like giving few mls of blood
for investigation, undergoing some medical examinations.
Will I be paid for the study?
No. you will not be paid.
Will my participating in this study, my personal details will be kept
confidentially?
Yes, confidentiality will be maintained.
Will I be informed of this study’s results and findings?
Yes, if you want you can get the details from us.
Can I withdraw from this study at any time during the study period?
Yes. You can withdraw at any time during the study period.
click to give detailed procedure involved for obtaining informed consent from the
participant or guardian & assent from the children
11 QUALITY CONTROL
Please give Quality Control and Assurance Procedures if applicable

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Name of Officer designated by the department for quality control:
Dr. Smrita Swamy
Designation: HOD, Department of radiology, MGMCRI
Telephone No: 04132616700
E-mail:
12 SPONSORSHIPS
Nil

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13 INVESTIGATORS DECLARATION
This is to certify that the protocol entitled “EVALUATION OF THYROID
NODULES USING THYROID IMAGING REPORTING AND DATA
SYSTEM(TIRADS) AND ITS HISTOPATHOLOGICAL CORRELATION” was
reviewed by us for submission to the SBV Institutional Ethics Committee and
certified that this protocol represents an accurate and complete description of the
proposed research. We have read the ICMR guidelines, ICP-GCP
guidelines/CPCSEA guidelines/and other applicable guidelines and undertake to
ensure that the rights and welfare of the study subjects are protected.
The study will be performed as per the approved protocol only. If any deviation is
warranted, the same will be presented to the ethical committee and permission will
be sought. We assure that the study will be terminated immediately in case of any
unforeseen adverse consequences and we will inform the same to the ethical
committee immediately.
Dr. PRIMARY GUIDE
Professor and Head of
Department of Speciality
Guide DD/MM/YYYY
Dr. CO GUIDE ONE
Associate Professor of Speciality
Co-guide DD/MM/YYYY
Dr. YOUR NAME
Department of
CANDIDATE/PI DD/MM/YYYY
Dr. Head of Department
Head of Department of Speciality
with Dept. Seal DD/MM/YYYY