ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography.

NCT06266026 | Recruiting DMC

• 1 other identifier: ThermoBreast
• Study Type: interventional
• Target: 28,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Artificial Intelligence; Thermography; breast imaging; breast diagnosis

Outcome Measures

Primary Outcomes (2)

• Sensitivity (true-positive rate)

  As our primary outcome we will use true-positive ThermoBreast results, i.e. detected invasive breast cancer by ThermoBreast (=index test) compared to histopathologically confirmed invasive breast cancer during routine breast cancer screening/imaging (=reference test). We will report this outcome as the true-positive rate (=TPR, rate of patients with non-detected invasive breast cancer by ThermoBreast compared to histopathologically confirmed invasive breast cancer during routine breast cancer screening/imaging) which is a commonly used and validated measure in diagnostic studies.

  up to 2 years of follow-up

• Specificity (true-negative rate)

  As a co-primary outcome we will measure the specificity of the ThermoBreast screening modality. The specificity will be defined as the rate of true-negative ThermoBreast results, i.e., the number of correctly identified absence of invasive breast cancer by ThermoBreast, when compared to the number of absence of histopathologically confirmed invasive breast cancer or regular follow-up imaging during routine breast cancer screening/imaging. This outcome will be reported as the true-negative rate (=TNR, rate of patients for whom ThermoBreast correctly identifies the absence of invasive breast cancer in alignment with the results from routine breast cancer screening/imaging).

  up to 2 years of follow-up

Secondary Outcomes (20)

• Cancer detection rate

  up to 2 years of follow-up

• Detection rate of ductal carcinoma in situ (DCIS)

  up to 2 years of follow-up

• Detection rate of tumor category pT1

  up to 2 years of follow-up

• Recall rate

  up to 2 years of follow-up

• Sensitivity

  up to 2 years of follow-up

Interventions

ThermoBreast - AI-based evaluation of dynamic breast thermography imaging DIAGNOSTIC_TEST

Index test: AI-based evaluation of dynamic breast thermography imaging (ThermoBreast). The ThermoBreast evaluation will be performed independently of the routine breast cancer diagnostic evaluation. Some baseline risk variables (e.g. patient age, hormonal status) may be included in the ThermoBreast evaluation. Reference test: Routine breast diagnostics will serve as a reference test against which the ThermoBreast outcome will be compared. Depending on national guidelines and clinical scenarios, routine breast cancer diagnostics can consist of several routine procedures, including clinical examination, ultrasound, mammography, tomosynthesis, MRI, follow-up imaging, biopsy, surgical excision, and histopathologic evaluation. All procedures will be performed as indicated and specified by the respective, current national guidelines.

Also known as: ThermoMind Vision One Device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• (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.

Sponsors & Collaborators

• ThermoMind Ltd.: lead
• Assuta Medical Centers Ltd.: collaborator
• Hospital of Lithuanian University of Health Sciences Kaunas Clinics: collaborator
• Institut Gustav Roussy: collaborator
• M.D. Anderson Cancer Center: collaborator
• Sheba Medical Center: collaborator
• Holy Family Hospital, Nazareth, Israel: collaborator
• University College Cork: collaborator
• Univerzitetni klinicni center Maribor: collaborator
• Academisch Ziekenhuis Groningen: collaborator
• Technical University of Munich: collaborator
• Technion, Israel Institute of Technology: collaborator
• Vrije Universiteit Brussel: collaborator
• Cancer Patients Europe: collaborator
• University Hospital Heidelberg: collaborator

Study Sites (1)

Heidelberg University Hospital

Heidelberg, Germany

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael Golatta, MD

  University Hospital Heidelberg

  STUDY DIRECTOR

• André Pfob, MD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hakan Yesilmen

CONTACT

+972 547833599; hakan@thermomind.io

Larisa Adamyan, PhD

CONTACT

+972 547833599; larisa@thermomind.io

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: February 20, 2024
• Study Start: December 11, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)