FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 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  
Status 
Not Applicable 
 
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. .  


 
Close