ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography. An International, Multicenter, Prospective Development and Validation Trial.
Trial ID: NCT06266026
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2023-12-11
Completion date: 2029-12
Sponsor: ThermoMind Ltd.
Collaborators: Assuta Medical Centers Ltd.; Hospital of Lithuanian University of Health Sciences Kaunas Clinics; Institut Gustav Roussy; M.D. Anderson Cancer Center; Sheba Medical Center; Holy Family Hospital, Nazareth, Israel; University College Cork; Univerzitetni klinicni center Maribor; Academisch Ziekenhuis Groningen; Technical University of Munich; Technion, Israel Institute of Technology; Vrije Universiteit Brussel; Cancer Patients Europe; University Hospital Heidelberg
Conditions: Breast Cancer
Interventions: ThermoBreast - AI-based evaluation of dynamic breast thermography imaging
Locations: Heidelberg University Hospital
Countries: Germany
Enrollment: 28000
Age range: 18 Years - None
Sex: FEMALE

Summary:
Breast cancer is one of the most worrisome health concerns facing women. Early detection and active patient monitoring are crucial to survival. The chances of a cure are high when detected and treated in the early stages. Standard breast cancer diagnostic methods such as mammography, ultrasound, and MRI have limitations such as ionizing radiation, high false-positive rates, and/or high expenses.

Medical Thermography might overcome these limitations: It is a non-invasive , adjunctive physiologic imaging technology that uses a high-resolution infrared camera and computer processing to produce an image (thermogram) of a patient's skin surface temperatures. It is a non-contact screening method, which does not involve radiation exposure or invasive procedures, and is safe for both the patient and the trained personnel performing the screening. While mammography and ultrasound depend primarily on structural and anatomical variation of the tumor from the surrounding breast tissue, thermography detects pathophysiological changes within the breast such as metabolic and vascular changes caused by cancer. The heat transfer in the body is conducted by the circulatory system; hence, pathologies identified by thermography are generally associated with changes in blood perfusion.

To date, there has been no completed or ongoing large-scale, prospective, multicenter, international study that evaluates the diagnostic performance of thermal video streams coupled with advanced Artificial Intelligence algorithms for early-stage breast cancer screening and diagnosis. The proposed study will be crucial for the development of a new imaging modality that aims to be both cost-effective and to carry a minimal level of risk, facilitating screening of women of all age groups and breast densities, enabling early detection of abnormalities caused by malignant processes and improving patient monitoring.

Eligibility 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.

Outcomes:
Sensitivity (true-positive rate); Specificity (true-negative rate)