| 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
|
|
|
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
|
|
|
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.Â
|
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. |