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

• ClinicalTrials.gov Identifier: NCT04688086
• Recruitment Status: Completed
• First Posted: December 29, 2020
• Last Update Posted: September 28, 2021
• Sponsor: Niramai Health Analytix Private Limited
• Collaborator: Max Healthcare Insititute Limited
• Information provided by (Responsible Party): Niramai Health Analytix Private Limited

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Breast Cancer; Early Detection of Cancer	Diagnostic Test: Thermalytix

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 459 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: December 15, 2018
• Actual Primary Completion Date: January 6, 2020
• Actual Study Completion Date: January 30, 2020

Groups and Cohorts

Group/Cohort

Intervention/treatment

Women with no personal history of breast cancer; 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.

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.

Outcome Measures

Primary Outcome Measures :

1. Sensitivity, specificity, positive predictive value and negative predictive value of Thermalytix [ Time Frame: End of study (1 year) ]
   To assess the clinical performance of Thermalytix as compared to standard screening modalities

Secondary Outcome Measures :

1. Sensitivity and specificity of Thermalytix for different patient characteristics [ Time Frame: End of study (1 year) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: The participant eligibility is based on self-representation of gender identity
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Women who came in for a breast mammography at Max Super Speciality Hospital, Saket were invited to take part in the study.

Criteria

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

Contacts and Locations

Locations

India

Max Healthcare Insititute Limited

New Delhi, India, 110017

Sponsors and Collaborators

Niramai Health Analytix Private Limited

Max Healthcare Insititute Limited

Investigators

• Principal Investigator: Richa Bansal, MD; Max Healthcare Insititute Limited

More Information

• Responsible Party: Niramai Health Analytix Private Limited
• ClinicalTrials.gov Identifier: NCT04688086
• Other Study ID Numbers: NIR-THERMA-02
• First Posted: December 29, 2020
• Last Update Posted: September 28, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The study protocol and clinical study report will be made available to investigators from academic institutions for non-commercial use and whose proposed use of the data has been approved by an independent review committee. The individual participant data would be shared for meta-analysis.
• Supporting Materials: Study Protocol; Clinical Study Report (CSR)
• Time Frame: 9 months after publication of results and ending 20 months following article publication, subject to approval from the Sponsor.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Niramai Health Analytix Private Limited:

Breast cancer; Thermography; Thermalytix; Artificial Intelligence; Machine Learning; Dense Breasts; Breast Density; Mammography; Breast Cancer Screening

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases