Circadian Thermal Sensing to Detect Breast Disease

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Early-Stage Breast Carcinoma

In brief

The purpose of this study is to determine if Cyrcadia's Circadian Biometric Recorder (CBR™), which is attached to soft biometric patches worn on the body, can improve early breast cancer detection along with mammography or as a stand alone device.

Key facts

Study ID

NCT02511301

Run by

Cyrcadia Health

People needed

173

Starts

2015-06-01

Expected to finish

2020-02-01

Last updated by the study team

2019-01-03

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women with a BI-RADS category 4 or 5 designation on mammogram
• Women with a BI-RADS category 4 or 5 designation on breast ultrasound
• Women with a BI-RADS category 4 or 5 designation on breast MRI
• Women who are willing to undergo a complete evaluation and/or biopsy procedure if recommended by the treating physician

You may not qualify if…

• Less than 21 years of age
• Unable to sign the consent form
• Pregnant or lactating
• Physically unable to wear the Cyrcadia CBR™ for 6 hours
• Previous mastectomy
• Any breast surgery or biopsy within the last 90 days
• Any trauma to the breast within the last 90 days
• Any biopsy or treatment for the BI-RADS category 4 or 5 abnormality
• Refusal to undergo recommended diagnostic evaluation of the BI-RADS category 4 or 5 abnormality

Where it is running

• El Camino Hospital — Mountain View, California, United States (enrolling)
• The Ohio State University, Stephanie Spielman Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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