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

First Sense Medical

Status: Suspended

Conditions: Thermography; Cancer, Breast; Breast Neoplasm Female

Treatments: Device: Sentinel BreastScan II

Study type: Observational

Funder types: Other

Identifiers

NCT03271853

SBS-001

Details and patient eligibility

About

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

Full 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 produce data which will be analyzed by Therma-Scan Reference Laboratory. Dr. Hoekstra, CEO of Therma-Scan, is the author of a published paper based on breast thermal data with a reported 95% sensitivity and 91% specificity. The SBS II examination will take approximately 7 minutes.

This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan. SBS II thermal breast data is an adjunctive aid to standard breast imaging. Currently, mammography is one of the standards of care in screening for visible signs of breast cancer. Breast thermology is the analysis of the heat signature data from an examined breast. All study costs will be incurred by the sponsor. Study subjects will incur no cost to participate. All scientific data revealed in this protocol will be used for the specific objectives of the study. The SBS II is a non-significant risk device. There is no contact with the subject during the entire procedure.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

2,000 participants in 1 patient group

SBS II

Treatment:

Device: Sentinel BreastScan II