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CTRI Number  CTRI/2025/08/093613 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 23/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   MEthods for LOcalization of Different types of breast lesions 
Scientific Title of Study   A prospective non-interventional multicenter cohort study to evaluate different imaging-guided methods for localization of malignant breast lesions 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NCT05559411  ClinicalTrials.gov 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jyoutishman Saikia 
Designation  Assistant Professor 
Affiliation  AIIMS New Delhi 
Address  Room no 14, Ground floor, Academic Building, NCI AIIMS, Jhajjar-124105
HOD Office, Room no 231, IRCH Building, 2nd floor, AIIMS Ansari Nagar-110029
South
DELHI
110029
India 
Phone  9612892050  
Fax    
Email  jyoutishman@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jyoutishman Saikia 
Designation  Assistant Professor 
Affiliation  AIIMS New Delhi 
Address  Room no 14, Ground floor, Academic Building, NCI AIIMS, Jhajjar-124105
HOD Office, Room no 231, IRCH Building, 2nd floor, AIIMS Ansari Nagar-110029
South
DELHI
110029
India 
Phone  9612892050  
Fax    
Email  jyoutishman@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jyoutishman Saikia 
Designation  Assistant Professor 
Affiliation  AIIMS New Delhi 
Address  Room no 14, Ground floor, Academic Building, NCI AIIMS, Jhajjar-124105
HOD Office, Room no 231, IRCH Building, 2nd floor, AIIMS Ansari Nagar-110029
South
DELHI
110029
India 
Phone  9612892050  
Fax    
Email  jyoutishman@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Egypt
France
Germany
Greece
India
Israel
Italy
Pakistan
Peru
Poland
Portugal
South Africa  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jyoutishman Saikia  All India Institute of Medical Sciences (AIIMS), New Delhi  Department of Surgical Oncology, NCI AIIMS New Delhi
South
DELHI 		 9612892050

jyoutishman@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. Signed consent
2. Malignant breast lesion requiring breast-conserving surgery and imaging-guided
localization (either DCIS or invasive breast cancer; multiple or bilateral lesions and
the use of neoadjuvant chemotherapy are allowed)
3. Planned surgical removal of the lesion using one or more of the following imaging guided
localization techniques (Wire, intraoperative USG, Dye, seed) 
 
ExclusionCriteria 
Details  1. Patients not suitable for surgical treatment
2. Patients requiring mastectomy as first surgery
3. Surgical removal without imaging-guided localization 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Intended target lesion and/or marker removal, independent of margin status on final
histopathology
2. Negative resection margin rates (defined as lesion removal with no invasive or
non-invasive carcinoma on ink) at first surgery 		 1. At Baseline before image-guided localisation
2. During Surgery
3. At 2 weeks after Surgery
4. At 4 weeks after Surgery 
 
Secondary Outcome  
Outcome  TimePoints 
- Rates of second surgery, mastectomy, resection ratio, marker dislocation rates
- Volume and weight of resected tissue
- Impact of experience of study sites on other outcome measures, depending on the
localization technique used
- Impact of self-reported ethnicity on other outcome measures
- Evaluation of surgical standards of care in different countries
- Evaluation of economic resources required for different localization techniques
(material costs, operative time etc.)
- Evaluation of MRI artifacts
- Evaluation of complication rates related to marker placement
- Evaluation of perioperative complication rates 		 post surgry 3monthly for 1 year 
 
Target Sample Size   Total Sample Size="500"
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   N/A 
Date of First Enrollment (India)   05/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/09/2025 
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 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  

This is a multivcentre international observational study. The aim of the proposed study is to comparatively evaluate different imaging-guided localization methods used for surgical removal of non-palpable malignant breast lesions with regard to oncological safety and patient-reported outcomes.

 
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