Breast CancerNCT04688086
A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers
An observational study of Breast Cancer and Early Detection of Cancer, run by Niramai Health Analytix Private Limited at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Early Detection of Cancer
- What is being tested?
- Thermalytix
- How many people
- 687 participants
- Where
- 1 siteIndia
- Study dates
- 15 Dec 2018to 30 Jan 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who came in for a breast mammography at Max Super Speciality Hospital, Saket were invited to take part in the study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Early Detection of Cancer
- Being tested
- Thermalytix
- Keywords
- Breast cancer, Thermography, Thermalytix, Artificial Intelligence, Machine Learning, Dense Breasts, Breast Density, Mammography, Breast Cancer Screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermalytixDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Thermalytix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of Thermalytix
To assess the clinical performance of Thermalytix as compared to standard screening modalities.
Sensitivity, specificity, positive predictive value and negative predictive value of Thermalytix
Measured: 2 days
Secondary outcomes (2)
Sensitivity and Specificity of Thermalytix for Women With Dense Breast Tissue (ACR Category C or D)
To assess the influence of patient characteristics (Breast density) on the diagnostic accuracy of Thermalytix.
Measured: 2 days
Sensitivity and Specificity of Thermalytix in Women With Breast Density ACR Category "A" or "B"
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"
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start15 Dec 2018
- Primary completion6 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 687 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niramai Health Analytix Private Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Max Healthcare Insititute Limited
- Responsible party
- Sponsor
- Investigators
- Richa Bansal, MD, Principal investigator, Max Healthcare Insititute Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688086
- Sponsor's protocol ID
- NIR-THERMA-02
- Status last verified
- Oct 2024
- First submitted
- 23 Dec 2020
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04688086
- Acronym / sponsor ID
- NIR-THERMA-02
- Conditions
- Breast Cancer, Early Detection of Cancer
- Keywords
- Breast cancer, Thermography, Thermalytix, Artificial Intelligence, Machine Learning, Dense Breasts, Breast Density, Mammography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 687 participants (actual)
- Lead sponsor
- Niramai Health Analytix Private LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Max Healthcare Insititute Limited
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Posted 17 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with no personal history of breast cancer | – | Diagnostic Test: ThermalytixWomen 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who came in for a breast mammography at Max Super Speciality Hospital, Saket were invited to take part in the study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThermalytixThermalytix 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. | Diagnostic test | Women with no personal history of breast cancer |
Primary outcome
Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of Thermalytix
Time frame: 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
2 secondary outcomes
Sensitivity and Specificity of Thermalytix for Women With Dense Breast Tissue (ACR Category C or D)
Time frame: 2 days
Sensitivity and Specificity of Thermalytix in Women With Breast Density ACR Category "A" or "B"
Time frame: 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richa Bansal, MD principal investigator
Max Healthcare Insititute Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Early Detection of Cancer, run by Niramai Health Analytix Private Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of Thermalytix (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.