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

NCT03271853 | Suspended FDA Device

• 1 other identifier: SBS-001
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Neoplasm Female; Cancer, Breast; Thermography

Outcome Measures

Primary Outcomes (1)

• Measure protocol accuracy

  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.

  Through study completion, an average of 4 years.

Study Arms (1)

SBS II

Device: Sentinel BreastScan II

Interventions

Sentinel BreastScan II 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.

SBS II

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male or Female, over the age of 18 years.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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:

• 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.

Sponsors & Collaborators

• First Sense Medical, LLC: lead
• University of Toledo Health Science Campus: collaborator

Study Sites (1)

Eleanor N. Dana Cancer Center, University of Toledo

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Haitham Elsamaloty

  University of Toledo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: September 5, 2017
• Study Start: November 3, 2017
• Primary Completion: September 1, 2021
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 10, 2018

Record last verified: 2018-01

Locations

US (1)