NCT04688086

A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers

Completed Results posted Last updated 17 October 2024

What this trial tests

trial testing Thermalytix in Breast Cancer in 687 participants. Completed in 30 January 2020.

Timeline

15 December 2018

Primary endpoint
6 January 2020

30 January 2020

Quick facts

Lead sponsor	Niramai Health Analytix Private Limited
Status	Completed
Study type	OBSERVATIONAL
Enrollment	687
Start date	15 December 2018
Primary completion	6 January 2020
Estimated completion	30 January 2020
Sites	1 location across India

Drugs / interventions tested

• Thermalytix

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Early Detection of Cancer — all drugs for Early Detection of Cancer →

Sponsor

Niramai Health Analytix Private Limited

Who can join

Adults 18 to 80, female only, with Breast Cancer or Early Detection of Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of Thermalytix Primary · 2 days

To assess the clinical performance of Thermalytix as compared to standard screening modalities. Sensitivity, specificity, positive predictive value and negative predictive value of Thermalytix

Sensitivity

Group	Value	95% CI
Women With no Personal History of Breast Cancer	95.24	76.18 – 99.88

Specificity

Group	Value	95% CI
Women With no Personal History of Breast Cancer	88.58	85.23 – 91.41

PPV

Group	Value	95% CI
Women With no Personal History of Breast Cancer	28.57	18.4 – 40.62

NPV

Group	Value	95% CI
Women With no Personal History of Breast Cancer	99.74	98.58 – 99.99

Sensitivity and Specificity of Thermalytix for Women With Dense Breast Tissue (ACR Category C or D) Secondary · 2 days

To assess the influence of patient characteristics (Breast density) on the diagnostic accuracy of Thermalytix.

Sensitivity

Group	Value	95% CI
Women With no Personal History of Breast Cancer	100	69.15 – 100

Specificity

Group	Value	95% CI
Women With no Personal History of Breast Cancer	81.65	74.72 – 87.35

Sensitivity and Specificity of Thermalytix in Women With Breast Density ACR Category "A" or "B" Secondary · 2 days

To assess the influence of patient characteristics (Breast density) on the diagnostic accuracy of Thermalytix. Sensitivity and Specificity of Thermalytix in Women with Fatty Breasts - Breast Density ACR category "A" or "B"

Sensitivity

Group	Value	95% CI
Women With no Personal History of Breast Cancer	90.9	73.9 – 100

Specificity

Group	Value	95% CI
Women With no Personal History of Breast Cancer	92.5	89.4 – 95.6

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A prospective evaluation of breast thermography enhanced by a novel machine learning technique for screening breast abnormalities in a general population of women presenting to a secondary care hospital.
   Bansal R, Collison S, Krishnan L, Aggarwal B, et al · · 2022 · cited 8× · PMID 36686848 · DOI 10.3389/frai.2022.1050803