Circadian Thermal Sensing to Detect Breast Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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The Cyrcadia CBR™ (Circadian Biometric Recorder) includes wearable biometric patches and a detachable data recording device. The CBR™ 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 CBR™ 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 CBR™ 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 CBR™ 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 CBR™, including the positive predictive value, negative predictive value, false negative rate and false positive rate. to determine the optimal wear time for the Cyrcadia CBR™. 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.

Official Title
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Circadian Thermal Sensing for the Detection of Breast Disease as a Supplemental Cancer Screening System

Conditions
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Early-Stage Breast Carcinoma

Intervention / Treatment
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* Device: Cyrcadia CBR™ device placement for abnormality screening


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyrcadia CBR™ Device<br>Cyrcadia CBR™ device, including adhesive patches on both breasts connected to a small recorder, is placed on the study subject for 2 to 24 hours. After the test period, the CBR™ will be removed and the data will be downloaded to a central site for analysis.There are no interventions after the CBR™ is removed from the Study Subject | Device: Cyrcadia CBR™ device placement for abnormality screening<br>* Cyrcadia CBR™ device, including adhesive patches on both breasts connected to a small recorder, is placed on the study subject for 2 to 24 hours. After the test period, the CBR™ will be removed and the data will be downloaded to a central site for analysis. There are no interventions after the CBR™ is removed from the Study Subject.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive Analytic Analysis (PAA) Sensitivity and Specificity | The data is analyzed using a predefined set of algorithms, referred to as Predictive Analytic Analysis (PAA) Outcome is measured by: NUMBER OF PATIENTS WHOSE INVESTIGATIVE CBR DEVISE RESULTS MATCH OF THOSE OF THE BIOPSY RESULTS. | 7 to 30 days after CBR placement |