Circadian Thermal Sensing to Detect Breast Disease
Primary Purpose
Early-Stage Breast Carcinoma
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cyrcadia CBR™ device placement for abnormality screening
Sponsored by
About this trial
This is an interventional screening trial for Early-Stage Breast Carcinoma
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 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
Sites / Locations
- El Camino HospitalRecruiting
- The Ohio State University, Stephanie Spielman Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cyrcadia CBR™ Device
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02511301
First Posted
June 18, 2015
Last Updated
January 1, 2019
Sponsor
Cyrcadia Health
Collaborators
Stanford University, Salesforce, Ohio State University
1. Study Identification
Unique Protocol Identification Number
NCT02511301
Brief Title
Circadian Thermal Sensing to Detect Breast Disease
Official Title
Circadian Thermal Sensing for the Detection of Breast Disease as a Supplemental Cancer Screening System
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
February 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cyrcadia Health
Collaborators
Stanford University, Salesforce, Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early-Stage Breast Carcinoma
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
173 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cyrcadia CBR™ Device
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Cyrcadia CBR™ device placement for abnormality screening
Intervention Description
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.
Primary Outcome Measure Information:
Title
Predictive Analytic Analysis (PAA) Sensitivity and Specificity
Description
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.
Time Frame
7 to 30 days after CBR placement
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Norell, B.A., CCRA
Phone
775-233-1211
Email
manorell@cyrcadiahealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Ellenhorn, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040-4378
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Amber, B.S., CCRP
Phone
650-962-4562
Email
kara_amber@elcaminohospital.com
Facility Name
The Ohio State University, Stephanie Spielman Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Learn more about this trial
Circadian Thermal Sensing to Detect Breast Disease
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