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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-03

Study Completion Date

2026-09-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Breast Neoplasm Female Cancer, Breast Thermography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SBS II

Sentinel BreastScan II

Intervention Type DEVICE

The SBS II will automate the recording of thermal data used in the Therma-Scan manual thermology protocol by utilizing a thermal camera sensitive to changes in breast temperature. The SBS II system uses a very sensitive thermography camera that detects and visually displays heat patterns that naturally emanate from the breast. SBS II captures this data digitally for subsequent analysis by Therma-Scan.

Interventions

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Sentinel BreastScan II

The SBS II will automate the recording of thermal data used in the Therma-Scan manual thermology protocol by utilizing a thermal camera sensitive to changes in breast temperature. The SBS II system uses a very sensitive thermography camera that detects and visually displays heat patterns that naturally emanate from the breast. SBS II captures this data digitally for subsequent analysis by Therma-Scan.

Intervention Type DEVICE

Eligibility Criteria

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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.

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes