| CTRI Number |
CTRI/2026/02/104327 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of ultrasound elastography in breast lumps and comparison with lab reports |
|
Scientific Title of Study
|
Diagnostic accuracy of shear wave elastography in characterization of breast lesions with histopathological 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 |
Deepti Naik |
| Designation |
Professor, Department of Radiodiagnosis and Imaging |
| Affiliation |
Sri Guru Ram Das University of health sciences and research |
| Address |
Room no. 13, Department of Radiodiagnosis and Imaging, Sri Guru Ram Das University of Health Sciences And Research, Vallah, Sri Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
9902044052 |
| Fax |
|
| Email |
drdeepti2004@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arvinder Singh |
| Designation |
Professor and Head, Department of Radiodiagnosis and Imaging |
| Affiliation |
Sri Guru Ram Das University of health sciences and research |
| Address |
Room no. 12, Department of Radiodiagnosis and Imaging, Sri Guru Ram Das University of Health Sciences And Research, Vallah, Sri Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
01832870277 |
| Fax |
|
| Email |
arvinderdr@radiffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashima Gupta |
| Designation |
Junior Resident, Department of Radiodiagnosis and Imaging |
| Affiliation |
Sri Guru Ram Das University of health sciences |
| Address |
Room no. 16, Department of Radiodiagnosis and Imaging, Sri Guru Ram Das University of Health Sciences And Research, Vallah, Sri Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
8847584229 |
| Fax |
|
| Email |
guptaashima087@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ram Das University Of Health Sciences And Research |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das University of Health Sciences and Research |
| Address |
Sri Guru Ram Das University of Health Sciences and Research, Vallah, Sri Amritsar 143501 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ashima Gupta |
Sri Guru Ram Das University of Health Sciences |
Room Number 4B, Ultrasound division, Departmnt of Radiodiagnosis & Imaging, Sri Amritsar,143501, India
Amritsar
PUNJAB |
8847584229
guptaashima087@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Patients presenting with breast lump on physical examination or lesion detected on ultrasonography. |
|
| ExclusionCriteria |
| Details |
Patient with history of prior breast surgery and
patients currently receiving or have completed radiotherapy, Acute pain/Tender breast lesions.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate diagnostic accuracy of shear wave elastography in characterization of breast lesions with histopathological correlation and to assess the stiffness in various types of breast lesions using SWE. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
02/03/2026 |
| 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="6"
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
|
Breast cancer is one of the most common malignancies among women worldwide, and early diagnosis plays a vital role in reducing morbidity and mortality. Conventional imaging methods have limitations in accurately differentiating benign from malignant lesions. Shear Wave Elastography (SWE) offers a promising non-invasive tool to assess tissue stiffness, which, when correlated with histopathology, enhances diagnostic accuracy. This study is significant as it explores the role of Shear Wave Elastography in accurately characterizing breast lesions. It may reduce unnecessary invasive procedures like biopsies by providing reliable, non-invasive diagnostic support. Ultimately, it can enhance early detection and improve management of breast cancer. |