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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04688086
• Other study ID #: NIR-THERMA-02
• Status: Completed
• Start date: December 15, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: September 2021
• Source: Niramai Health Analytix Private Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

While mammography is the most accepted breast cancer screening test, it is less sensitive in women with dense breast tissue, who have a four fold high risk for developing breast cancer. Thermalytix is a novel automated breast cancer screening solution that uses artificial intelligence (AI) over thermal images to detect and localise breast cancer lesions in women. In this study the performance of Thermalytix over mammography is evaluated in women with dense and non-dense breast tissue who presented for a health check-up at a hospital. All women underwent Thermalytix and mammography, and participants who were reported as positive on either test were recommended for further investigations. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated across age-groups, menopausal status, and breast densities against the current standard-of-care diagnostic modalities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: January 30, 2020
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Early Detection of Cancer

Intervention

Diagnostic Test:
• Thermalytix
Thermalytix is an Artificial intelligence based automated breast screening solution that analyzes thermal distribution on the breast to generate a breast health score automatically. Thermal imaging was performed by a trained technician to capture thermal images of the participant in five views. These thermal images were uploaded to Thermalytix software on the cloud where it was automatically analyzed by AI-based Thermalytix computer-aided detection (CADe) engine. This CADe engine analyzes uploaded thermal images and outputs an interpretation report for each participant with quantitative scores corresponding to computed probability of malignancy based on the structural, vascular, areolar, thermal properties of the observed abnormality. Thermalytix also generates annotated images with markings of abnormal regions and an overall Thermalytix score suggesting likelihood of breast malignancy. The locked AI model Thermalytix algorithm version 3, dated December 2018 was used for the analysis.

Locations

Country	Name	City	State
India	Max Healthcare Insititute Limited	New Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Niramai Health Analytix Private Limited	Max Healthcare Insititute Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, specificity, positive predictive value and negative predictive value of Thermalytix	To assess the clinical performance of Thermalytix as compared to standard screening modalities	End of study (1 year)
Secondary	Sensitivity and specificity of Thermalytix for different patient characteristics	To assess the influence of patient characteristics, such as age, menopausal status, breast density on the diagnostic accuracy of Thermalytix. The patient characteristics will be collected through a questionnaire.	End of study (1 year)