Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.

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Conditions studied: Breast Neoplasm Female, Cancer, Breast, Thermography

In brief

This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan.

Key facts

Study ID

NCT03271853

Run by

First Sense Medical, LLC

People needed

2000

Starts

2017-11-03

Expected to finish

2026-09-01

Last updated by the study team

2018-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Eleanor N. Dana Cancer Center, University of Toledo — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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