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

Suspended

• Conditions: Thermography; Cancer, Breast; Breast Neoplasm Female
• Interventions: Device: Sentinel BreastScan II

• Registration Number: NCT03271853
• Lead Sponsor: First Sense Medical, LLC

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 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.

Study Timeline

• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-05
• Study Start: 2017-11-03
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-10
• Primary Completion: 2021-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SBS II	Sentinel BreastScan II	-

Primary Outcome Measures

Name	Time	Method
Measure protocol accuracy	Through study completion, an average of 4 years.	To measure the sensitivity and specificity of thermographic analysis based on the Marseilles analytic protocol \[ Th 1 thru 5 \] to biopsy results predicated on standard breast imaging criteria \[ BIRADS analytical protocol, B1 thru B5 \]. The resultant BIRADS score and biopsy pathological results will be compared to thermographic analysis \[ Th1 thru 5 \] for each subject. 50 subjects undergoing both thermography and standard breast imaging leading to biopsy \[ BIRADS 3 thru 5 \] will then be compared by measuring the results of each, BIRADS for standard breast imaging v the Marseilles Th system used in thermographic analysis, for concordance or discordance of findings as measured on final pathological analysis. This analysis will be performed for each subsequent 50 patient cohort undergoing standard mammographic/ultrasound breast imaging analysis.

Trial Locations

Locations (1)

Eleanor N. Dana Cancer Center, University of Toledo; 🇺🇸 Toledo, Ohio, United States