N/A
Completed N=687
A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers
Breast Cancer · Early Detection of Cancer
Source: ClinicalTrials.gov NCT04688086 ↗
Enrolled (actual)
687
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of Thermalytix — 95.24; 88.58; 28.57; 99.74 percentage
Summary
The purpose of this study is to determine the clinical performance of AI-based Thermalytix with the current standard-of-care diagnostic modalities in women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of Thermalytix |
95.24; 88.58; 28.57; 99.74 | — |
| SECONDARY Sensitivity and Specificity of Thermalytix for Women With Dense Breast Tissue (ACR Category C or D) |
100; 81.65 | — |
| SECONDARY Sensitivity and Specificity of Thermalytix in Women With Breast Density ACR Category "A" or "B" |
90.9; 92.5 | — |
Eligibility Criteria
Inclusion Criteria
- Female subjects equal to and above 18 years
- Subjects who are willing to give written informed consent for study participation
- Subjects who are ready to comply with the study related visits and procedures
Exclusion Criteria
- Subjects who are pregnant
- Subjects who are lactating
- Subjects who have undergone either lumpectomy or mastectomy
- Subjects who have undergone chemotherapy in the last 2 weeks at the time of study enrollment
- Any active illness, psychological and/or pathological condition that would interfere with study participation in the opinion of the Investigator
Data sourced from ClinicalTrials.gov (NCT04688086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.