Status:
COMPLETED
A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers
Lead Sponsor:
Niramai Health Analytix Private Limited
Collaborating Sponsors:
Max Healthcare Insititute Limited
Conditions:
Breast Cancer
Early Detection of Cancer
Eligibility:
FEMALE
18-80 years
Brief Summary
The purpose of this study is to determine the clinical performance of AI-based Thermalytix with the current standard-of-care diagnostic modalities in women.
Detailed Description
While mammography is the most accepted breast cancer screening test, it is less sensitive in women with dense breast tissue, who have a four fold high risk for developing breast cancer. Thermalytix is...
Eligibility Criteria
Inclusion
- Female subjects equal to and above 18 years
- Subjects who are willing to give written informed consent for study participation
- Subjects who are ready to comply with the study related visits and procedures
Exclusion
- Subjects who are pregnant
- Subjects who are lactating
- Subjects who have undergone either lumpectomy or mastectomy
- Subjects who have undergone chemotherapy in the last 2 weeks at the time of study enrollment
- Any active illness, psychological and/or pathological condition that would interfere with study participation in the opinion of the Investigator
Key Trial Info
Start Date :
December 15 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2020
Estimated Enrollment :
687 Patients enrolled
Trial Details
Trial ID
NCT04688086
Start Date
December 15 2018
End Date
January 30 2020
Last Update
October 17 2024
Active Locations (1)
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1
Max Healthcare Insititute Limited
New Delhi, India, 110017