Clinical trial NCT03271853: Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.
Official title: Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Breast Neoplasm Female
Cancer, Breast
Thermography
Lead sponsor: First Sense Medical, LLC
Sponsor class: OTHER
Collaborators: name: University of Toledo Health Science Campus
First posted: 2017-09-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consists of any patient undergoing standard mammographic examination and/or any additional imaging study predicated on the results of mammography.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measure protocol accuracy
timeFrame: Through study completion, an average of 4 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: United States
facility: Eleanor N. Dana Cancer Center, University of Toledo
state: Ohio
Study officials:
affiliation: University of Toledo
name: Haitham Elsamaloty
role: PRINCIPAL_INVESTIGATOR
References: