| CTRI Number |
CTRI/2025/07/090573 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the Role of Additional Scans in Planning Surgery and Improving Outcomes in Women with Newly Diagnosed Breast Cancer |
|
Scientific Title of Study
|
A PRospective evaluation of impact of additional Imaging modalities in Surgical Management and outcome in Treatment naive breast Cancer patients. |
| Trial Acronym |
PRiISM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Palak Thakkar |
| Designation |
PROFESSOR and OIC BREAST IMAGING and INTERVENTION SERVICES |
| Affiliation |
Tata Memorial Centre |
| Address |
Tata Memorial Hospital
Main Building Ground Floor
Radiology Department Room No 125
Dr Borges Road Parel
Tata Memorial Hospital
Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177155 |
| Fax |
|
| Email |
dr.palakp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Palak Thakkar |
| Designation |
PROFESSOR and OIC BREAST IMAGING and INTERVENTION SERVICES |
| Affiliation |
Tata Memorial Centre |
| Address |
Tata Memorial Hospital
Main Building Ground Floor
Radiology Department Room No 125
Dr Borges Road Parel
Tata Memorial Hospital
Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177155 |
| Fax |
|
| Email |
dr.palakp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejal vijay ogale |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Tata Memorial Centre |
| Address |
Tata Memorial Hospital
Main Building Ground Floor
Radiology Department Room No 125
Dr Borges Road Parel
Tata Memorial Hospital
Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9022351956 |
| Fax |
|
| Email |
ogaletejal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Tata Memorial Centre
Dr. Borges Road, Parel Mumbai |
| Type of Sponsor |
Government funding agency |
|
|
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 Palak Thakkar |
Tata Memorial Centre |
Tata Memorial Centre
Main Building ground floor
Dept of Radiology
Dr E Borges Road Parel
Mumbai
MAHARASHTRA |
022417155
dr.palakp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee II |
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 |
| Intervention |
DA of MRI and DA of CEM |
DA of MRI and DA of CEM |
| Comparator Agent |
HPR as gold standard |
HPR as gold standard |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1. Patients consenting for participation in the study.
2. Non-metastatic at the time of presentation.
3. cT1-4 and cN0-3 at the time of presentation.
4. Mammogram, USG, CEM and MRI either performed in TMH, or done outside, with adequate quality DICOM images uploaded on PACS.
5. Patients undergoing CEM guided or MRI guided or relook USG guided biopsy if indicated at TMH/ACTREC; but may not undergo breast conservative surgery {These patients will be included in the study as rad- path correlation of these additional findings will be available}
6. Patients undergoing surgical and/ or medical management at TMH/ACTREC.
7. Biopsy specimen if eligible and complete surgical specimen provided to our institutional pathology department.
|
|
| ExclusionCriteria |
| Details |
Pregnant patients.
Metastatic disease at the time of presentation.
More than 18 years of age.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of proportion of change in surgical plan due to contrast based imaging findings.
Events considered as change in surgical plan due to additional findings will be following categories:
Category 1. Breast conservative surgery to mastectomy
Category 2. Mastectomy to breast conservative surgery
Category 3. For cases remaining as breast conservative surgery, extended resection leading to either expected change in cosmesis or requirement of oncoplasty due to contrast based imaging finding will be considered as change in management.
Category 4. Decision to start NACT.
|
at 6 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of disease extent on non-contrast-based imaging (Mammogram, USG), based on CEM and/or MRI (the modality which will determined the surgical outcome) & clinically determined extent of disease with histopathological extent of disease.
2. Diagnostic accuracy of contrast imaging detected additional findings with histopathology correlation as a gold standard.
|
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
15/07/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.palak@gmail.com].
- For how long will this data be available start date provided 30-06-2025 and end date provided 31-12-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective interventional study is designed to evaluate the role of additional pre-operative imaging modalities Magnetic Resonance Imaging (MRI) and Contrast-Enhanced Mammography (CEM) in optimizing the surgical management of treatmen naive breast cancer patients. Eligible patients with newly diagnosed, biopsy confirmed invasive breast cancer who have not received any prior treatment will first undergo standard imaging workup including mammography and ultrasound. Subsequently, participants will receive MRI and/or CEM within two weeks prior to planned surgery. The surgical team will use all imaging data to determine the extent and type of surgery needed. The study aims to assess how MRI and CEM influence surgical decision making by measuring changes in surgical plans, additional lesion detection rates, and the concordance between imaging findings and final histopathology. Post-operative outcomes including margin status, reoperation rates, and complications will be documented. Follow-up assessments will be conducted up to three months after surgery to monitor patient recovery and surgical efficacy. The study seeks to provide evidence on whether incorporating MRI and CEM improves surgical outcomes and patient management in breast cancer care. |