Clinical trial · Observational
Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.
NCT03271853CI-TRIAL-00031119suspendedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Trial temporarily halted to conduct additional device testing to verify cooling data. This temporary halt is NOT due to a potential risk to subject safety.
Summary
Brief summary (as posted)
This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm Female | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Thermography | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel BreastScan II | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- SBS II
- interventionNames
- Device: Sentinel BreastScan II
Primary outcomes (1)
- measure
- Measure protocol accuracy
- timeFrame
- Through study completion, an average of 4 years.
- description
- To measure the sensitivity and specificity of thermographic analysis based on the Marseilles analytic protocol \[ Th 1 thru 5 \] to biopsy results predicated on standard breast imaging criteria \[ BIRADS analytical protocol, B1 thru B5 \]. The resultant BIRADS score and biopsy pathological results will be compared to thermographic analysis \[ Th1 thru 5 \] for each subject. 50 subjects undergoing both thermography and standard breast imaging leading to biopsy \[ BIRADS 3 thru 5 \] will then be compared by measuring the results of each, BIRADS for standard breast imaging v the Marseilles Th system used in thermographic analysis, for concordance or discordance of findings as measured on final pathological analysis. This analysis will be performed for each subsequent 50 patient cohort undergoing standard mammographic/ultrasound breast imaging analysis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or Female, over the age of 18 years of age. * Asymptomatic women or women who are being screened for breast abnormality. * Women scheduled for a mammogram or women who have had a mammogram and are given 3 days to wait in between their mammogram and scheduled biopsy and FS/TS system. * Not pregnant or breast feeding. * Signed Informed consent. Exclusion Criteria: * Subject does not meet inclusion criteria, noted above. * Use of 100 mg or more of niacin by tablet or niacin patch within the last 24 hours. * Use of nitroglycerin within the last 24 hours. * Subject experienced a fever of 102°F or higher within thirty-six (36) hours of the study. * Subject must not have had a mammogram, breast ultrasound, or breast exam within the last 72 hours prior to the SBS II.
References
Publications (0)
Data not yet available
No reference posted for this study.