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CTRI Number  CTRI/2024/03/063796 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 26/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Other (Specify) [Ultrasonography]  
Study Design  Single Arm Study 
Public Title of Study   Role of elastography (imaging on ultrasound) in breast cancer patients recieving chemotherapy to predict responders and non responders. chemotherapy before surgery in breast cancer patients. 
Scientific Title of Study   Role of Shear wave elastography in assessment of response to neoadjuvant chemotherapy (NACT) in breast cancer patients. 
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 Purvi Haria 
Designation  Assistant Professor and Consultant, Department of radiology 
Affiliation  Tata Memorial Hospital, Parel 
Address  Main Building, Radiology Reporting Room No 66, Depatrtment of Radiology, TATA MEMORIAL HOSPITAL. Dr. E Borges Road, Parel, Mumbai, 400 012

Mumbai
MAHARASHTRA
400012
India 
Phone  9820789362  
Fax    
Email  drpurvianand@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Divyanshi 
Designation  Junior Resident- II, Department of radiology, Tata Memorial Hospital, Parel 
Affiliation  Tata Memorial Hospital, Parel 
Address  Main Building, Radiology Reporting Room No 66, Depatrtment of Radiology, TATA MEMORIAL HOSPITAL. Dr. E Borges Road, Parel, Mumbai - 400 012

Mumbai
MAHARASHTRA
400012
India 
Phone  7006321268  
Fax    
Email  drdivyanshimahajan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Divyanshi 
Designation  Junior Resident- II, Department of radiology, Tata Memorial Hospital, Parel 
Affiliation  Tata Memorial Hospital, Parel 
Address  Main Building, Radiology Reporting Room No 66, Depatrtment of Radiology, TATA MEMORIAL HOSPITAL. Dr. E Borges Road, Parel, Mumbai - 400 012

Mumbai
MAHARASHTRA
400012
India 
Phone  7006321268  
Fax    
Email  drdivyanshimahajan@gmail.com  
 
Source of Monetary or Material Support  
Intramural funding from Tata Memorial Hospital, Parel 
 
Primary Sponsor  
Name  Tata Memorial Hospital, Parel 
Address  TATA MEMORIAL HOSPITAL. Dr. E Borges Road, Parel, Mumbai - 400 012 
Type of Sponsor  Other [Organisation] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Divyanshi  Tata Memorial Hospital, Parel  Room No 115 B, Homi Bhabha block, Department of radiology, Main Building, TATA MEMORIAL HOSPITAL.
Mumbai
MAHARASHTRA 
7006321268

drdivyanshimahajan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-II, Tata Memorial Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Ultrasonography  110 (sample size) breast cancer patients on neoadjuvant chemotherapy will undergo an additional ultrasonographic evaluation after 2 cycles of chemotherapy (Intervention) and elastography values will be compared with the baseline ultrasonographic examination (Standard of care). Study duration is 2 years. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. HPR proven Operable breast cancer patients, planned for treatment (NACT + Surgery) in TMH
2. Age more than 18 years
3. Oligometastatic disease where treatment intent is curative 
 
ExclusionCriteria 
Details  1. Metastatic disease
2. Cystic lesion– elastography is not useful
3. DCIS with no measurable mass on USG
4. Inflammatory breast cancer
5. Pregnancy
6. Patients whose pre chemotherapy images are incomplete
7. Treatment defaulters (Patients who refuse, delay or discontinue treatment at any
time point during the study) and those who receive any treatment outside TMH. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess role of shear wave elastography in predicting the responders vs non
responders to NACT in breast cancer patients. 
2 years 
 
Secondary Outcome  
Outcome  TimePoints 
To predict pathological complete response in responders using elastography values. 
 
2 years 
Subset analysis of different types and grades of breast cancers for response to NACT.  2 years 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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   Phase 2 
Date of First Enrollment (India)   15/03/2024 
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 - NO
Brief Summary  

Breast cancer is one the most common cancer occurring in the world and in India. Breast cancer treatment includes chemotherapy, surgery and radiotherapy. In some stages of breast cancer, size of tumor is large without metastasis to other sites of body. In this stage of tumor, chemotherapy (NACT- Neo Adjuvant Chemo Therapy) is given before the surgery to decrease size of tumor so that less extensive surgery can be performed. In this proposed study, we are trying to study response to this chemotherapy (NACT) using elastography. Elastography measures hardness (stiffness) of tissue. Elastography is performed along with sonography of breast using the same machine where additional measurements (of stiffness of tissue) are taken along with routine sonographic evaluation.  Our hypothesis here is, as the patient is on chemotherapy, the hardness of the tissue should decrease and so should the values on elastography and if this decrease in elastography values correlates with final outcome of patient on histopathology report. 

For the study the patient will have to undergo additional ultrasonographic evaluation (intervention) post 2 cycles of chemotherapy, the values of which which will be compared to baseline ultrasonography parameters (Performed as standard of care in TMH). We will finally evaluate if elastography values can predict responders vs non responders to NACT.

The patient will not be charged for this intervention. If a certain patient does not come or denies this additional investigation or denies to be a part of the study at any given time, that patient will not be included in the study and standard of care will not be affected.

 
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