- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04688086
A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers
September 22, 2021 updated by: Niramai Health Analytix Private Limited
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
459
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Delhi, India, 110017
- Max Healthcare Insititute Limited
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
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.
Description
Inclusion Criteria:
- Female subjects equal to and above 18 years
- Subjects who are willing to give written informed consent for study participation
- Subjects who are ready to comply with the study related visits and procedures
Exclusion Criteria:
- Subjects who are pregnant
- Subjects who are lactating
- Subjects who have undergone either lumpectomy or mastectomy
- Subjects who have undergone chemotherapy in the last 2 weeks at the time of study enrollment
- Any active illness, psychological and/or pathological condition that would interfere with study participation in the opinion of the Investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Sensitivity, specificity, positive predictive value and negative predictive value of Thermalytix
Time Frame: End of study (1 year)
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To assess the clinical performance of Thermalytix as compared to standard screening modalities
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End of study (1 year)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Sensitivity and specificity of Thermalytix for different patient characteristics
Time Frame: End of study (1 year)
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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.
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End of study (1 year)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Richa Bansal, MD, Max Healthcare Insititute Limited
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 15, 2018
Primary Completion (ACTUAL)
January 6, 2020
Study Completion (ACTUAL)
January 30, 2020
Study Registration Dates
First Submitted
December 23, 2020
First Submitted That Met QC Criteria
December 23, 2020
First Posted (ACTUAL)
December 29, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 28, 2021
Last Update Submitted That Met QC Criteria
September 22, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIR-THERMA-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing Time Frame
9 months after publication of results and ending 20 months following article publication, subject to approval from the Sponsor.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Thermalytix
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University of ArizonaSuspended