Circadian Thermal Sensing to Detect Breast Disease

NCT02511301 | Unknown Phase 1

• 1 other identifier: CH001
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 2

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.

Conditions

Early-Stage Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cyrcadia CBR™ Device

EXPERIMENTAL

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

Interventions

Cyrcadia CBR™ device placement for abnormality screening 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

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cyrcadia Health: lead
• Stanford University: collaborator
• Salesforce: collaborator
• Ohio State University: collaborator

Study Sites (2)

El Camino Hospital

Mountain View, California, 94040-4378, United States

RECRUITING

The Ohio State University, Stephanie Spielman Comprehensive Cancer Center

Columbus, Ohio, 43212, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joshua Ellenhorn, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Norell, B.A., CCRA

CONTACT

775-233-1211; manorell@cyrcadiahealth.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: July 30, 2015
• Study Start: June 1, 2015
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: January 3, 2019

Record last verified: 2018-12

Locations

US (2)