Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
173 participants
INTERVENTIONAL
2015-06-30
2020-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Cyrcadia CBR™ Device
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
Cyrcadia CBR™ device placement for abnormality screening
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.
Interventions
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Cyrcadia CBR™ device placement for abnormality screening
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
FEMALE
No
Sponsors
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Stanford University
OTHER
Salesforce
UNKNOWN
Ohio State University
OTHER
Cyrcadia Health
INDUSTRY
Responsible Party
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Principal Investigators
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Joshua Ellenhorn, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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El Camino Hospital
Mountain View, California, United States
The Ohio State University, Stephanie Spielman Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CH001
Identifier Type: -
Identifier Source: org_study_id
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