Status:
SUSPENDED
Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.
Lead Sponsor:
First Sense Medical, LLC
Collaborating Sponsors:
University of Toledo Health Science Campus
Conditions:
Breast Neoplasm Female
Cancer, Breast
Eligibility:
All Genders
18+ years
Brief Summary
This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan.
Detailed Description
FirstSense Medical, LLC is a medical device company which has developed a breast cancer screening device, the Sentinel BreastScan II \[SBS II\]. This radiation free device is being developed to produc...
Eligibility Criteria
Inclusion
- Male or Female, over the age of 18 years of age.
- Asymptomatic women or women who are being screened for breast abnormality.
- Women scheduled for a mammogram or women who have had a mammogram and are given 3 days to wait in between their mammogram and scheduled biopsy and FS/TS system.
- Not pregnant or breast feeding.
- Signed Informed consent.
Exclusion
- Subject does not meet inclusion criteria, noted above.
- Use of 100 mg or more of niacin by tablet or niacin patch within the last 24 hours.
- Use of nitroglycerin within the last 24 hours.
- Subject experienced a fever of 102°F or higher within thirty-six (36) hours of the study.
- Subject must not have had a mammogram, breast ultrasound, or breast exam within the last 72 hours prior to the SBS II.
Key Trial Info
Start Date :
November 3 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT03271853
Start Date
November 3 2017
End Date
September 1 2026
Last Update
January 10 2018
Active Locations (1)
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1
Eleanor N. Dana Cancer Center, University of Toledo
Toledo, Ohio, United States, 43614