ThermoBreast clinical study officially registered at ClinicalTrial.gov

Exciting updates from the ThermoBreast project! We are thrilled to announce that our clinical trial has been officially registered at ClinicalTrials.gov. This milestone marks a significant step forward in our project, as it will enable the ThermoBreast consortium to conduct a comprehensive and standardised evaluation of the Vision One thermal imaging device developed by the project coordinator, ThermoMind Ltd. As we shared earlier, some of our partner clinical sites have started recruiting the first paints into our ThermoBreast clinical trial. This brings us one step closer to our goal of a less invasive and more accurate method of breast cancer detection, which could result in earlier diagnosis and better treatment outcomes. Our team is optimistic that this technology will lead to earlier detection and improved treatment outcomes for patients. Ultimately, we hope that this technology will eventually become a standard screening tool and help in the fight against breast cancer.

This ThermoBreast study is designed as a multicenter, prospective, blinded, three cohorts, diagnostic trial. Patients will be recruited at 11 centres in France, Germany, Ireland, Israel, Slovenia, Lithuania, and the US. The primary objective is to compare the diagnostic performance of advanced image processing AI models to automatically predict breast malignancy based on thermograms and individual patient data collected during breast examination (ThermoBreast) with routine breast cancer screening and imaging. The study population consists of women undergoing routine screening for breast cancer or diagnostic evaluation of suspicious breast masses. The study will recruit women into three cohorts: Screening cohort, High-Risk Screening, and Diagnostics cohort. Participants recruited for the study will be assigned to a dedicated cohort based on the reason for the visit.

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.