Breast Cancer Clinical Trial
Circadian Thermal Sensing to Detect Breast Disease
Summary
The purpose of this study is to determine if Cyrcadia's Circadian Biometric Recorder (CBRâ„¢), 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.
Full Description
The Cyrcadia CBRâ„¢ (Circadian Biometric Recorder) includes wearable biometric patches and a detachable data recording device. The CBRâ„¢ records chronobiologic data while the patient is totally ambulatory and going about her normal daily routine. Following removal of the detachable data recording device from the wearable biometric patches, the data is transferred to a computer for analysis. The Cyrcadia CBRâ„¢ will be placed on the patient for the duration of 2 to 24 hours. There is no restriction of daily activity. The study subject is requested to sponge bathe rather than shower while wearing the device, keeping the device dry during the testing procedure. After this period, the CBRâ„¢ will be removed and the data will be transferred to a computer for analysis.
The primary endpoint of this 173 patient study is to determine the accuracy of Cyrcadia CBRâ„¢ as a supplemental screening device to mammography and ultrasound in predicting a diagnosis of breast cancer. Specific emphasis will be on the utilization of the CBR as a secondary screening device to reduce the number of biopsies currently performed on non-cancerous tissue. A secondary emphasis will be on the CBR to act as an improved screening solution over mammography specifically in those patients with dense breast parenchymal tissue.
Other endpoints of the study are:
to determine the accuracy of Cyrcadia CBRâ„¢, including the positive predictive value, negative predictive value, false negative rate and false positive rate.
to determine the optimal wear time for the Cyrcadia CBRâ„¢.
to demonstrate substantial equivalent or improved results when applied to Cyrcadia original patient case study with identical advanced neural network analysis computational results.
Study subjects will be followed at 6, 12, 18, and 24 months to update their clinical status.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Less than 21 years of age
Unable to sign the consent form
Pregnant or lactating
Physically unable to wear the Cyrcadia CBRâ„¢ 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
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There are 2 Locations for this study
Columbus Ohio, 43212, United States
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