| CTRI Number |
CTRI/2025/05/087545 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Diagnostic Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying Different Ways to Plan Surgery for Breast Cancer Patients Who Responded Well to Chemotherapy |
|
Scientific Title of Study
|
Comprasion of methods of margin delineation for vaccum-assisted excision in Breast cancer patients with radilogical complete response post neoadjuvant chemotherapy |
| 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 Krithika Rangarajan |
| Designation |
Associate professor Radiology |
| Affiliation |
AIIMS, Delhi |
| Address |
room no -160 1st Floor Institute Rotary Cancer Hospital, IRCH road, Ansari Nagar East, AIIMS Campus, New Delhi, Delhi 110029
South DELHI 110029 India |
| Phone |
9810488850 |
| Fax |
|
| Email |
krithikarangarajan@aiims.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Krithika Rangarajan |
| Designation |
Associate professor Radiology |
| Affiliation |
AIIMS, Delhi |
| Address |
room no 160 1st floor Institute Rotary Cancer Hospital, IRCH road, Ansari Nagar East, AIIMS Campus, New Delhi, Delhi 110029
South DELHI 110029 India |
| Phone |
9810488850 |
| Fax |
|
| Email |
krithikarangarajan@aiims.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Krithika Rangarajan |
| Designation |
Associate professor Radiology |
| Affiliation |
AIIMS, Delhi |
| Address |
room no 160, 1st floor Institute Rotary Cancer Hospital, IRCH road, Ansari Nagar East, AIIMS Campus, New Delhi, Delhi 110029
South DELHI 110029 India |
| Phone |
9810488850 |
| Fax |
|
| Email |
krithikarangarajan@aiims.edu |
|
|
Source of Monetary or Material Support
|
| Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
All India Institute Of Medical Sciences Delhi, pincode- 110029, India |
|
|
Primary Sponsor
|
| Name |
AIl India Institute of Medical Sciences Delhi |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029, India
All India Institute Of Medical Sciences Delhi, address 110029, India |
| Type of Sponsor |
Government 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 Krithika Rangarajan |
All India Institute of Medical Sciences New Delhi |
Room no 160 - B, Department of Radiology, Dr. BRAIRCH, AIIMS, New Delhi South DELHI |
9810488850
krithikarangarajan@aiims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bracketing |
Marker clip would be inserted at edge of mass pre-chemotherapy to mark margin of vacuum excision |
| Comparator Agent |
Standard technique |
Clip placed at the centre of the mass would be excised with a 1 cms margin around it |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients with breast cancer who have undergone NACT and have a complete response on mammography and ultrasound.
Patients in whom breast localisation clip has been placed.
|
|
| ExclusionCriteria |
| Details |
Patients with extensive intraductal components on initial biopsy.
Patients with extensive microcalcifications on initial mammography in addition to mass.
Patients without accurate localisation by means of a clip, in whom mass cannot be accurately localised on mammogram after NACT.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feasibility, concordance with surgical pathology |
Time point is at the time of surgery in both cases, which is atleast 2 weeks after completion of NACT
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| n/a |
n/a |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
04/06/2025 |
| 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="2" 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 - NO
|
|
Brief Summary
|
Breast cancer is currently the most common cancer among women in India, with most cases being diagnosed at advanced stages. There is a growing role of NACT for management of breast cancer with some chemotherapy resulting in complete disappearance of the mass on preoperative imaging. However, a radiological complete response may not corroborate with pathological complete response in about 60% of patients, necessitating the need for surgical resection of the tumour bed. Ultrasound or Mammography guided Vacuum Assisted tumour bed Excision (VAE) is an attractive minimally invasive option for tumor resection in certain scenarios like in patients with complete radiological response which is under investigation worldover to prove or disprove complete pathological response. Several studies indicate that adequate Vacuum Assisted Excision can accurately determine whether pathological complete response has been achieved, thus introducing the possibility of surgical deescalation. However since vacuum involves suction of tissue, margin determination is impossible. However, accurate excision of the entire tumor bed with adequate margin determination is important to prevent local recurrence which however is quite challenging at present. We propose and compare two methods of margin determination for VAE along with protocol for performing VAE. The 1st method is using two wires for bracketing the tumor bed t. The 2nd approach utilizes multidirectional VAE in the epicenter of tumor bed and a fixed predetermined distance around it for adequate excision. Additionally, we also propose to collect the data of the patient for development of machine learning techniques to identify the margins of the tumor bed in real time and thus guide VAE. .
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