Circadian Thermal Sensing to Detect Breast Disease

January 1, 2019 updated by: Cyrcadia Health

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

173

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Mountain View, California, United States, 94040-4378
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Active, not recruiting
        • The Ohio State University, Stephanie Spielman Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive Analytic Analysis (PAA) Sensitivity and Specificity
Time Frame: 7 to 30 days after CBR placement
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyrcadia Health

Collaborators

Stanford University
Ohio State University
Salesforce

Investigators

  • Principal Investigator: Joshua Ellenhorn, MD, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ANTICIPATED)

February 1, 2020

Study Completion (ANTICIPATED)

February 1, 2020

Study Registration Dates

First Submitted

June 18, 2015

First Submitted That Met QC Criteria

July 28, 2015

First Posted (ESTIMATE)

July 30, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2019

Last Update Submitted That Met QC Criteria

January 1, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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