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CTRI Number  CTRI/2024/02/062338 [Registered on: 06/02/2024] Trial Registered Prospectively
Last Modified On: 01/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Computer enabled autofluorescence device for the diagnosis of breast lumps and determining completeness of surgical removal of breast tumours 
Scientific Title of Study   Design and development of a machine learning enabled autofluorescence device for preoperative breast lump diagnosis and intraoperative breast tumor margin assessment 
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 Krishna Kishore Mahato 
Designation  Professor and HoD Department of Biophysics 
Affiliation  Manipal School of Life Sciences, Manipal 
Address  Department of Biophysics Manipal School of Life Sciences Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448836553  
Fax    
Email  mahato.kk@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Stanley Mathew 
Designation  Professor of General Surgery 
Affiliation  Kasturba Medical College Manipal 
Address  Department of General Surgery 3rd Floor Smt Sharadha Madhav Pai OPD Building Kasturba Hospital Manipal

Udupi
KARNATAKA
576104
India 
Phone  9844409900  
Fax    
Email  stanley.mathew@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Badareesh L  
Designation  Professor of General Surgery 
Affiliation  Kasturba Medical College Manipal 
Address  Department of General Surgery 3rd Floor Smt Sharadha Madhav Pai OPD Building Kasturba Hospital Manipal

Udupi
KARNATAKA
576104
India 
Phone  8861038876  
Fax    
Email  badareesh.l@manipal.edu  
 
Source of Monetary or Material Support  
Office of The Director-General Indian Council of Medical Research Department of Health Research Ministry of Health and Family Welfare V.Ramalingaswamy Bhawan Ansari Nagar New Delhi-110029. BMI/ePMS/121273 INVESTIGATOR-INITIATED RESEARCH PROPOSALS FOR SMALL EXTRAMURAL GRANTS 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V Ramalingaswami Bhawan P O Box No 4911 Ansari Nagar New Delhi 110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Dean  Kasturba Medical College Manipal 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Stanley Mathew  Kasturba Hospital Manipal  Department of General Surgery 3rd Floor Smt Sharadha Madhav Pai OPD Building Kasturba Hospital Manipal
Udupi
KARNATAKA 		 9844409900

stanley.mathew@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, (2) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Novel class C device to detect autofluorescence spectra from breast tissue  Breast lump or whole breast is excised during the Standard of Care surgery. A novel Class C device is passed transiently (less than 5 minutes) into the breast tumour and the surface of the excised lump is also studied for tumor on the surface or margins of the resected Wide Local Excision specimen The total duration of the study is 1 year 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  1. Benign or malignant lump in the breast
2. Patients planned for surgical excision of lump (Lumpectomy and Wide Local Excision) or removal of the breast (Mastectomy)
 
 
ExclusionCriteria 
Details  1. Patients below 18 years age
2. Male patients
3. Patients not willing or not planned for surgical excision of breast lump
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Ability to differentiate autofluorescence spectral signatures of normal, benign and malignant tissues in the breast by using the novel investigational device in ex-vivo condition  1 hour 
 
Secondary Outcome  
Outcome  TimePoints 
Ability of a machine learning model to differentiate normal, benign and malignant
spectral signatures obtained from the breast tissue 		 1 year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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/ Phase 3 
Date of First Enrollment (India)   10/02/2024 
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)  Open to Recruitment 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response (Others) -  Researchers and reviewers of journals

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Wrriten request for sharing data

  6. For how long will this data be available start date provided 01-04-2025 and end date provided 01-04-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

Adult female patients with a breast lump will be seen by a consultant surgeon in the Department of General Surgery, Kasturba Hospital, Manipal. She will get admitted if a surgical intervention is mandated as Standard of Care for the condition. The surgeon / clinician co-Investigator will obtain informed consent from the patient. Only patients consenting for the study, after she has been  explained in the language she understands, will be enrolled into the study. Patient and disease associated data as mentioned in the proforma will be obtained from the medical records of the patient

 

For this first phase of the study, after the specimen is removed by the consultant as a part of standard of care, the novel device will be passed into the specimen (ex vivo) in the OT itself. Recording of spectra will be done and archived. After the recordings are completed the specimen will be sent to pathology lab, where the pathologist will bisect the specimen and further recordings of spectra will be done from the surface and within the lump. After all recordings are completed, the specimen will be processed by the pathology department for routine HPE. There is no additional blood or tissue sample harvested from the patient. There are no follow up visits.


After the spectral signatures are obtained, a machine learning algorithm (software) will be tested to improve the sensitivity, specificity, positive predictive value and negative predictive value of the device in real time in comparison to the HPE diagnosis 

 
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