| CTRI Number |
CTRI/2021/06/034325 [Registered on: 21/06/2021] Trial Registered Prospectively |
| Last Modified On: |
18/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
MRI to check Response to chemotherapy in Breast cancer patients
|
|
Scientific Title of Study
|
Mid-cycle MRI to predict Complete Pathologic Response to Neoadjuvant chemotherapy in Breast cancer patients
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aantriksha Arunkumar Gupta |
| Designation |
Junior Resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Radiodiagnosis and Imaging,
Kasturba hospital,
Manipal,
Udupi.
Udupi
KARNATAKA
576104
India |
| Phone |
9137177205 |
| Fax |
|
| Email |
gupta.arunkumar@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakashini K |
| Designation |
Professor and Head |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Radiodiagnosis and Imaging,
Kasturba hospital,
Manipal,
Udupi.
Udupi
KARNATAKA
576104
India |
| Phone |
9845053325 |
| Fax |
|
| Email |
prakashini.k@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aantriksha Arunkumar Gupta |
| Designation |
Junior resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Radiodiagnosis and Imaging,
Kasturba hospital,
Manipal,
Udupi.
Udupi
KARNATAKA
576104
India |
| Phone |
9137177205 |
| Fax |
|
| Email |
gupta.arunkumar@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Radiodiagnosis and Imaging,
Kasturba hospital,
Hebri Road,
Madhav nagar,
Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Smiti Sripathi Research Award For Breast Imaging Endowment Fund |
| Address |
Finance office,
Kasturba medical college,
Hebri road,
Madhav nagar,
Manipal,
Udupi - 576104,
Karnataka. |
| 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 Aantriksha Gupta |
Kasturba Hospital |
Department of Radiodiagnosis and Imaging,
Hebri road,
Madhav nagar,
Manipal
Udupi
Udupi
KARNATAKA |
9137177205
gupta.arunkumar@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH 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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Patients diagnosed with Early breast cancer being treated with Neoadjuvant chemotherapy. Patients diagnosed with Locally advanced breast cancer, being treated with Neoadjuvant chemotherapy. Baseline and mid-cycle MRI (taken after 3 cycles of chemotherapy) to be taken. |
|
| ExclusionCriteria |
| Details |
Patients with metastatic carcinoma of breast.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
MRI study (DCE/DWI) of breast, taken Mid-cycle of Neoadjuvant chemotherapy, in Breast cancer patients, effectively helps predict complete pathological response after completion of NAC in Breast cancer patients.
|
One and half year |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
21/06/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an observational prospective study of patients undergoing Neoadjuvant chemotherapy for treatment of Early/Locally advanced breast cancer at Kasturba Hospital, Manipal. Patients will be selected based on above mentioned inclusion and exclusion criteria. Two MRIs shall be planned - before initiation of chemotherapy and after three cycles. The difference in ADC values in Diffusion weighted sequences and Contrast-enhancement in post-contrast sequences and their relation to complete pathological response to the chemotherapy will be analyzed. The study shall help conclude that MRI scans help predict the complete pathological response to Neoadjuvant chemotherapy via changes in ADC values and post-contrast images. |