Clinical trial · Interventional
Circadian Thermal Sensing to Detect Breast Disease
Circadian Thermal Sensing for the Detection of Breast Disease as a Supplemental Cancer Screening System
NCT02511301CI-TRIAL-00036318unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-Stage Breast Carcinoma | Early Stage Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyrcadia CBR™ device placement for abnormality screening | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cyrcadia CBR™ Device
- 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
- interventionNames
- Device: Cyrcadia CBR™ device placement for abnormality screening
Primary outcomes (1)
- measure
- Predictive Analytic Analysis (PAA) Sensitivity and Specificity
- timeFrame
- 7 to 30 days after CBR placement
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.