Clinical trial NCT04688086: A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Early Detection of Cancer
Keywords: Breast cancer
Thermography
Thermalytix
Artificial Intelligence
Machine Learning
Dense Breasts
Breast Density
Mammography
Breast Cancer Screening
Lead sponsor: Niramai Health Analytix Private Limited
Sponsor class: INDUSTRY
Collaborators: name: Max Healthcare Insititute Limited
First posted: 2020-12-29
Enrollment: 687
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of Thermalytix
timeFrame: 2 days
Secondary outcomes:
measure: Sensitivity and Specificity of Thermalytix for Women With Dense Breast Tissue (ACR Category C or D)
timeFrame: 2 days
measure: Sensitivity and Specificity of Thermalytix in Women With Breast Density ACR Category "A" or "B"
timeFrame: 2 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Max Healthcare Insititute Limited
Study officials:
affiliation: Max Healthcare Insititute Limited
name: Richa Bansal, MD
role: PRINCIPAL_INVESTIGATOR
References: