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CTRI Number  CTRI/2023/07/054888 [Registered on: 06/07/2023] Trial Registered Prospectively
Last Modified On: 01/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Breast tumor imaging using ultrasound 
Scientific Title of Study   Breast Tumor Heterogeneity Quantification using Ultrasound-based Shearwave ELastography 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Avinash Eranki PhD 
Designation  Assistant Professor 
Affiliation  Indian Institute of Technolgy Hyderabad 
Address  Room No.301, Department of Biomedical Engineering
Kandi, Sangareddy
Hyderabad
TELANGANA
502284
India 
Phone  9986820250  
Fax    
Email  aeranki@bme.iith.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Avinash Eranki 
Designation  Assistant Professor 
Affiliation  Indian Institute of Technolgy Hyderabad 
Address  Room No.301, Department of Biomedical Engineering
Kandi, Sangareddy
Hyderabad
TELANGANA
502284
India 
Phone  9986820250  
Fax    
Email  aeranki@bme.iith.ac.in  
 
Details of Contact Person
Public Query  
Name  Avinash Eranki PhD 
Designation  Assistant Professor 
Affiliation  Indian Institute of Technolgy Hyderabad 
Address  Room No.301, Department of Biomedical Engineering
Kandi, Sangareddy
Hyderabad
TELANGANA
502284
India 
Phone  9986820250  
Fax    
Email  aeranki@bme.iith.ac.in  
 
Source of Monetary or Material Support  
Room no. 301, Department of Biomedical Engineering, Indian Institute of Technology Hyderabad, Kandi, Sangareddy - 502284 
 
Primary Sponsor  
Name  Indian Institute of Technology Hyderabad 
Address  Room 301, Department of Biomedical Engineering,Indian Institute of Technology Hyderabad, Kandi, Sangareddy - 502284 
Type of Sponsor  Other [Govt. Research and Academic Institution] 
 
Details of Secondary Sponsor  
Name  Address 
Indian Institute of Technology Hyderabad  Room no. 301, Depaertment of Biomedical Engineereing, Indian Institute of Technology Hyderabad, Kandi, Sangareddy - 502284 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Avinash Eranki  Chennai Breast Center  South Beach Avenue, 47, S Beach Ave 1st St, MRC Nagar, Raja Annamalai Puram, Chennai, Tamil Nadu 600028
Chennai
TAMIL NADU 		 9986820250

aeranki@bme.iith.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chennai Breast Center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B||Imaging,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL in both intervention and comparator   NIL in both intervention and comparator  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients consenting to participate in the study
2. Age 18 or above
3. Primary breast tumor (with or without metastases)
4. Adequate clinical parameters for breast tumor ultrasound imaging
5. Ability to maintain a supine position during the study
 
 
ExclusionCriteria 
Details  1. Pregnant or currently lactating female participants
2. Significant renal or hepatic impairment
3. Uncontrolled illness or medical conditions that hinder ultrasound imaging
4. Skin ulceration or issues affecting the proper placement of ultrasound transducer
5. Inability to tolerate required position or procedure during the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Collect 2D/3D images (B-mode & shear wave elastography) of breast tumors using ultrasound to assess the heterogeneity of breast tumors.  First clinical visit 
 
Secondary Outcome  
Outcome  TimePoints 
1. Acquire 2D/3D ultrasound images of breast tumors using techniques such as B-mode imaging & color Doppler imaging.
2. Establish correlations between ultrasound measurements & mammographic data, immunohistochemistry (IHC) results, additional imaging modalities, clinical information, disease stage, treatment response, and clinical outcomes.
3. Evaluate the potential of 2D/3D ultrasound and shear wave as a predictive marker for breast tumor heterogeneity.
 		 First clinical visit 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   26/06/2024 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be made available on the publisher website

  6. For how long will this data be available start date provided 01-03-2026 and end date provided 01-03-2027?
    Response (Others) -  Once the manuscript is published

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - No
Brief Summary   The study aims to advance our understanding of the role of ultrasound imaging in quantifying the heterogeneity of breast tumors (across different sub-types) and its correlation with immunohistochemistry, 2D/3D mammography, and potential therapeutic response. 
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