Non-contact breast cancer imaging using AI-enhanced thermography
ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography. An International, Multicenter, Prospective Development and Validation Trial.
This study is testing a new non-invasive imaging method using AI to see if it can help detect breast cancer better than the usual screening methods for women in different risk groups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | ThermoMind Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT06266026 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a non-invasive imaging technique called ThermoBreast, which utilizes AI-enhanced thermography to detect breast cancer. The study will recruit women across multiple centers in France, Germany, Ireland, Israel, Slovenia, Lithuania, and the US, and will compare the diagnostic performance of this method against standard breast cancer screening techniques. Participants will be divided into three cohorts based on their screening needs: routine screening, high-risk screening, and diagnostic evaluation. The trial aims to improve early detection of breast cancer while minimizing the risks associated with traditional imaging methods.
Who should consider this trial
Good fit: Ideal candidates include women aged 40 to 74 for routine screening and women aged 18 and above with a genetic predisposition or family history of breast cancer.
Not a fit: Patients who are not female or those who do not meet the age and screening criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more accurate early detection of breast cancer, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using thermography for breast cancer detection, but the application of AI in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Screening cohort * Female subjects aged 40 to 74 years old (inclusive) presenting for routine mammography/tomosynthesis breast cancer screening according to national/regional guidelines * Subjects who are willing to give written informed consent for study participation * Subjects who are able to understand the character and individual consequences of the clinical trial and who are ready to comply with the study related visits and procedures * High-risk screening cohort * Female subjects aged 18 and above presenting for intensified high-risk breast cancer screening due to genetic predisposition or family history according to national/regional guidelines * Subjects who are willing to give written informed consent for study participation * Subjects who are able to understand the character and individual consequences of the clinical trial and who are ready to comply with the study related visits and procedures * Diagnostics cohort * Female subjects aged 18 and above presenting for intensified aftercare after a history of breast cancer, patients with symptoms (nipple discharge, breast lump based on physician physical exam or self-breast exam), patients who were referred for additional examination (MRI, Ultrasound, fine-needle aspiration cytology (FNAC) or biopsy) based on suspicious imaging findings in either breast * Subjects who are willing to give written informed consent for study participation * Subjects who are able to understand the character and individual consequences of the clinical trial and ready to comply with the study related visits and procedures Exclusion Criteria • (High-risk) Screening and Diagnostics cohort * Subjects who are pregnant or lactating * Subjects who have undergone lumpectomy or mastectomy in the last 4 months at the time of study enrollment * Subjects who have undergone cancer therapy (chemotherapy, start of hormonal therapy, radiotherapy, surgery) in the last 4 months at the time of study enrollment * Subjects who have undergone a breast biopsy in the last 2 months at the time of study enrollment * No subject will be allowed to enrol in this trial more than once.
Where this trial is running
Heidelberg
- Heidelberg University Hospital — Heidelberg, Germany (Recruiting)
Study contacts
- Principal investigator: André Pfob, MD — University Hospital Heidelberg
- Study coordinator: Hakan Yesilmen
- Email: hakan@thermomind.io
- Phone: +972 547833599
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.