| CTRI Number |
CTRI/2026/03/106427 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Study of Ultrasound Methods to Detect Cancer Risk in Thyroid Nodules Compared with Needle Testing |
|
Scientific Title of Study
|
Shear Wave Elastography and ACR- TIRADS Classification in the Evaluation of Thyroid Nodules: A Diagnostic Accuracy Study with FNAC Correlation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deval Rishi Pandit |
| Designation |
Radio-diagnosis Resident |
| Affiliation |
Rohilkhand Medical College & Hospital |
| Address |
Room no 1034, Department of Radiodiagnosis, Rohilkhand Medical College & Hospital, Bareilly.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7011175863 |
| Fax |
|
| Email |
deval23july@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohit Agarwal |
| Designation |
Associate professor |
| Affiliation |
Rohilkhand Medical College & Hospital |
| Address |
Room no 1034, Department of radio-diagnosis, Rohilkhand Medical College & Hospital.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9582235310 |
| Fax |
|
| Email |
deval23july@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deval Rishi Pandit |
| Designation |
Radio-diagnosis Resident |
| Affiliation |
Rohilkhand Medical College & Hospital |
| Address |
Room no 1034, Department of radio-diagnosis, Rohilkhand Medical College & Hospital.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7011175863 |
| Fax |
|
| Email |
deval23july@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rohilkhand Medical College & Hospital |
| Address |
4, Pilibhit Bypass Rd, Pawan Vihar, Bareilly, Uttar Pradesh 243006 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deval Rishi |
Rohilkhand Medical College and Hospital |
Room no 1034, Department of radio-diagnosis, Rohilkhand Medical College & Hospital.
Bareilly
UTTAR PRADESH |
7011175863
deval23july@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RMCH, Bareilly, U.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E041||Nontoxic single thyroid nodule, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fine Needle Aspiration Cytology |
Fine Needle Aspiration Cytology will be done based on clinical judgment or if required USG guided. FNAC reports will be used as the reference standard for final diagnosis.SWE and TIRADS data will be compared with cytological findings to assess diagnostic accuracy |
| Intervention |
Shear wave elastography |
All cases with thyroid nodule meeting the inclusion criteria will undergo B mode ultrasonography and shear wave elastography using the Samsung V7 ultrasound machine, in conjunction with a linear transducer. To ensure consistency, the ultrasound machine settings will be standardised to maintain the same thyroid ultrasound scanning preset throughout the study period.
Standard ultrasound scanning protocols will be followed to conduct the thyroid scans. The patient will lie in supine position with minimal extension of the neck with face away from the side of interest. After applying coupling gel to the exposed neck area of interest, the transducer will be used to acquire one transverse and one longitudinal image of each target nodule in grey scale and SWE modes.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Adult patients with thyroid nodule detected on clinical examination or Ultrasound
2) Nodules ranging from 5 mm to 50 mm in maximum diameter.
|
|
| ExclusionCriteria |
| Details |
1) History of thyroidectomy.
2) Multinodular disease without distinct isolated nodules.
3) Completely cystic nodules.
4) Nodules that are too large to be entirely visualized within the SWE acquisition box.
5) Nodules with macrocalcifications (as these interfere with elastographic assessment).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), Accuracy, Area Under the ROC Curve (AUROC)of SWE and ACR-TIRADS individually and in combination for differentiating benign and malignant thyroid nodules. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the diagnostic performance of TIRADS, SWE, & FNAC in differentiating benign & malignant thyroid nodules. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Shear Wave Elastography (SWE) is a relatively advanced imaging modality that is not yet widely available across all medical colleges and hospitals in India. It is typically found only in high-end ultrasound machines, limiting its widespread clinical use. Given that our department is equipped with this advanced technology, this study presents a valuable opportunity to utilize the available resources effectively and contribute to the growing body of evidence supporting its role in thyroid nodule characterization. There are limited studies evaluating the use of Shear Wave Elastography (SWE) in conjunction with TIRADS for improving the clinical assessment and risk stratification of thyroid nodules, particularly in resource-limited settings and among diverse ethnic and clinical populations like those in our country. Most of the studies (e.g., Gao et al., Celletti et al., Baz et al.) are retrospective which may introduce selection and reporting bias. This limits the external validity of their findings. This study would avoid such bias due its prospective nature. |