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

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

Interventions

DIAGNOSTIC_TEST

ThermoBreast - AI-based evaluation of dynamic breast thermography imaging

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.

Sponsors & Collaborators

• Assuta Medical Centers Ltd.

  collaborator UNKNOWN

• Hospital of Lithuanian University of Health Sciences Kaunas Clinics

  collaborator UNKNOWN

• Institut Gustav Roussy

  collaborator UNKNOWN

• M.D. Anderson Cancer Center

  collaborator OTHER

• Sheba Medical Center

  collaborator OTHER_GOV

• The Holy Family Hospital Nazareth

  collaborator UNKNOWN

• University College Cork

  collaborator OTHER

• Univerzitetni klinicni center Maribor

  collaborator UNKNOWN

• Academisch Ziekenhuis Groningen

  collaborator OTHER

• Technical University of Munich

  collaborator OTHER

• Technion, Israel Institute of Technology

  collaborator OTHER

• Vrije Universiteit Brussel

  collaborator OTHER

• Cancer Patients Europe

  collaborator UNKNOWN

• University Hospital Heidelberg

  collaborator OTHER

• ThermoMind Ltd.

  lead INDUSTRY

Principal Investigators

• Michael Golatta, MD · University Hospital Heidelberg

• André Pfob, MD · University Hospital Heidelberg

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-11

Primary Completion

2028-12-31

Completion

2029-12-31

Countries

• Germany

Study Locations