Clinical trial · Observational
A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers
A Prospective Study to Evaluate the Effectiveness of Thermalytix (AI-based Thermographic Solution Developed by Niramai) for Breast Cancer Screening as Compared to Standard Screening Modalities for Breast Cancer
NCT04688086CI-TRIAL-00081688completedResults postedClinicalTrials.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 the clinical performance of AI-based Thermalytix with the current standard-of-care diagnostic modalities in women.
Conditions
Conditions (2)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Early Detection of Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thermalytix | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women with no personal history of breast cancer
- description
- Women who came in for a breast mammography between ages 30 and 80 years were invited to take part in the study. All the women included in the study underwent breast cancer screening first by Thermalytix, the AI-based thermal imaging test, followed by mammography.
- interventionNames
- Diagnostic Test: Thermalytix
Primary outcomes (1)
- measure
- Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of Thermalytix
- timeFrame
- 2 days
- description
- To assess the clinical performance of Thermalytix as compared to standard screening modalities. Sensitivity, specificity, positive predictive value and negative predictive value of Thermalytix
Secondary outcomes (2)
- measure
- Sensitivity and Specificity of Thermalytix for Women With Dense Breast Tissue (ACR Category C or D)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female subjects equal to and above 18 years 2. Subjects who are willing to give written informed consent for study participation 3. Subjects who are ready to comply with the study related visits and procedures Exclusion Criteria: 1. Subjects who are pregnant 2. Subjects who are lactating 3. Subjects who have undergone either lumpectomy or mastectomy 4. Subjects who have undergone chemotherapy in the last 2 weeks at the time of study enrollment 5. Any active illness, psychological and/or pathological condition that would interfere with study participation in the opinion of the Investigator
References
Publications (0)
Data not yet available
No reference posted for this study.