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CTRI Number  CTRI/2025/07/091198 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 17/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Preventive
Screening 
Study Design  Other 
Public Title of Study   Thermalytix Breast imaging at KEM Hospital  
Scientific Title of Study   A Prospective Observational Study to evaluate the Clinical Performance of Thermalytix against Standard Breast Imaging Modalities for detecting breast malignancies in asymptomatic and symptomatic women. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Shilpa Rao 
Designation  HOU, Department of General Surgery 
Affiliation  KEM Hospital 
Address  Seth GS Medical College and KEM Hospital, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9821114002  
Fax  9821114002  
Email  shilparao@kem.edu  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Shilpa Rao 
Designation  HOU, Department of General Surgery 
Affiliation  KEM Hospital 
Address  Seth GS Medical College and KEM Hospital, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9821114002  
Fax  9821114002  
Email  shilparao@kem.edu  
 
Details of Contact Person
Public Query  
Name  Prof Dr Shilpa Rao 
Designation  HOU, Department of General Surgery 
Affiliation  KEM Hospital 
Address  Seth GS Medical College and KEM Hospital, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9821114002  
Fax  9821114002  
Email  shilparao@kem.edu  
 
Source of Monetary or Material Support  
SMILE Council, STARTUP Incubation Center OF Brihanmumbai MUNICPAL CORPORATION  
 
Primary Sponsor  
Name  Dr Shilpa Rao 
Address  Seth GS Medical College and KEM Hospital Acharya Donde Marg,Parel, Mumbai. 
Type of Sponsor  Other [Principle Investigator] 
 
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 
Prof Dr Shilpa Rao  SETH GSMC & KEM HOSPITAL  Room No 9, Breast Services Division, Department of General Surgery, Dr Ernest Borges Rd, Parel, Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA 		 91-9821114002

shilparao@kem.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee KEM Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  preventative or screening interventions 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Mammography and Breast Ultrasound  Standard Breast Imaging Modalities which is a combination of Mammography and Breast Ultrasound Imaging modalities will be used as comparator. For participants found suspicious of breast malignancy, MRI and Biopsy will be performed for final diagnosis.  
Intervention  Thermalytix  Thermalytix is a Software medical device that analyzes thermal distribution on breast to generate quantitative analysis report. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1. Women aged between 30 to 80 years who are either asymptomatic or symptomatic (with breast related symptoms)
2. Capable of understanding the investigational nature of the study and all pertinent aspects of study
3. Capable of signing and providing written consent in accordance with institutional and federal guidelines
4. Willing and able to comply with scheduled visits, treatment plan, and follow up with research staff 
 
ExclusionCriteria 
Details  Participants who fulfil any of the following criteria will be excluded from the study:
1. Women who are pregnant or lactating
2. Women who are in their menstrual cycle at the time of any of the imaging scans
3. Women with prior history of breast cancer, breast surgeries including implants; lumpectomy or surgery <1 year, h/o mastectomy with reconstruction
4. Women who are currently undergoing breast cancer treatment including chemotherapy or radiotherapy in the last 6 months
5. Women who are undergoing hormonal therapy
6. Unable to complete study-related procedures
7. Patients not willing to undergo USG/Biopsy/MRI if indicated
8. Incapable of or not willing to give consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Non inferiority by 10% in Sensitivity of Thermalytix when compared to Standard of care (Mammography and USG) for detecting histopath-confirmed-malignant lesions  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the community prevalence of breast cancer amongst urban females in Mumbai region.  12 months 
To compare the patient experience of Thermalytix in comparison with Mammography, Breast Ultrasound, & their combination in detecting breast abnormalities based on PSQ-18 scale.  12 months 
To assess the cost effectiveness & cost effecinecy using a model & feasibility of conducting Thermalytix screening for population  12 months 
To assess the Sensitivity & Specificity of Thermalytix in comparison with Mammography, Breast Ultrasound, & their combination in detecting breast abnormalities, with a specific focus on their performance in identifying true-positive cases when compared to histopathological findings.  12 months 
 
Target Sample Size   Total Sample Size="6000"
Sample Size from India="6000" 
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)   01/08/2025 
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   The proposed study is a comprehensive, prospective cohort study aiming to evaluate the efficacy of Thermalytix, a novel AI-based diagnostic tool, in comparison to the standard of care breast imaging modalities for detecting suspicious breast lesions among both asymptomatic and symptomatic women aged 30-80 years. The study will take place at Breast Services Clinic, Department of General Surgery, Seth GSMC and KEM Hospital, Mumbai, and follows a meticulously structured protocol. Prior to imaging procedures, CHVs will engage with the local population as a part of their routine job and will disseminate the details of the BMC breast screening centers in BMC offices. The imaging phase comprises two-view screening mammography and whole breast ultrasound, conducted by trained radiologists at designated centers. The results are graded on the BIRADS scale, with BIRADS 1 and 2 participants not proceeding to the next phase. Participants with BIRADS 3, 4, or 5 results undergo histopathology at KEM Hospital following clinical examination. The study also encompasses the assessment of Thermalytix’s feasibility for population screening, gauging patient experiences in comparison to standard imaging modalities, and collecting demographic data to better understand the affected population. This study design, with its comprehensive approach to breast health screening, follows established medical practices for breast cancer diagnosis and offers a holistic evaluation of novel diagnostic technology’s potential impact in a real-world setting. 
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