PATIENTS

ThermoBreast conducts the largest prospective clinical examination of its kind at 11 clinical centers around the world to validate its solution and demonstrate its clinical advantages in comparison to other screening methods.

How is ThermoBreast clinical study organised?

The clinical study recruits women to one of two study groups: Screening or Diagnostics groups. Participants are assigned to a dedicated group based on the reason of the visit. These are presenting for standard breast cancer screening or high-risk group patients and women referred for additional screenings. Participants will be screened with the thermal imaging device that is operated by a certified technician or a nurse. The screening takes around 15 minutes, it is safe, harmless and comfortable for the participant. During the screening, the thermal sensors capture thermal streams of the chest area, which will further be analysed with artificial intelligence to identify abnormal thermal patterns indicating breast cancer. The ThermoBreast clinical study is blinded, which means the results of the study-specific thermogram are hidden from the physicians responsible for the breast cancer screening procedure to ensure unbiased outcomes. All participants will be followed up for 3 years. The participating countries currently include Israel, Germany, France, Ireland, Lithuania, Slovenia and the USA.

Number of Patients Screened

as of today

Clinical sites conducting ThermoBreast clinical study

FAQ

Clinical study is a type of research that involves volunteers (participants of the study) and aims to add knowledge to a medical field. It may involve development of new treatments, drugs or preventive methods and aim to see what effect do they have on people. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. ThermoBreast is an interventional study.

You may find more information on clinical studies here:
Learn about Clinical Trials

Why should I participate?

Even though thermography has been mainly used as a supplementary tool for mammography, a number of conducted studies have confirmed its potential to be an independent, safe and reliable tool for earlier breast cancer detection and prediction. This has been propelled by the recent improvement of infrared sensors and the development of computer vision models. As a volunteer for the ThermoBreast project, you have the chance to make an impact on the future of breast cancer screening for yourself, your loved ones, and future generations. This is an incredible opportunity to help improve the lives of people all around the world.

What are eligibility criteria?

All clinical trials have rules about who can and cannot participate. These rules are called “eligibility criteria” but may also be referred to as inclusion/exclusion criteria. The criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. The eligibility criteria define the patient population that is being studied and are designed to protect the safety of participants in the trial.

Am I eligible for ThermoBreast?

You can take part in ThermoBreast clinical study if you are:

aged 18-74 years old;
not pregnant or lactating;
have not undergone lumpectomy or mastectomy in the last 4 months at the time of study enrollment;
have not undergone any kind of cancer therapy (chemotherapy, hormonal therapy, radiotherapy, surgery) in the last 4 months at the time of study enrollment;
have not undergone biopsy in the last 2 months at the time of study enrollment.

Take a look at the detailed inclusion and exclusion criteria of the ThermoBreast clinical trial below.

Is ThermoBreast screening procedure painful or dangerous?

Thermography is a non–invasive, non–contact, and radiation–free imaging technology that utilizes an infrared camera to create an image (thermogram) of a patient’s skin temperature. This procedure is safe for both the patient and the technician conducting the screening, as it does not involve radiation exposure or any other invasive procedures.

How long is ThermoBreast study?

The study duration for individual patients will be maximally up to 3 years.

Can I stop participating?

Participation in the study is voluntary, you can withdraw at any time.

Who can I contact if I am concerned about data processing?

The ThermoBreast study has been approved by the National Committees for Medical and Health Research Ethics and we put every effort to ensure that you’re comfortable with your participation. However, if you have any concerns or complaints about the study, please feel free to contact the project coordinator at: contact@thermobreast.eu

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.

Reach out to us

ThermoBreast Survey on Breast Cancer Screenings

We at ThermoBreast understand how daunting the thought of a mammogram or other screening can be and how much bravery it sometimes takes to simply go through the whole process.

That’s why we are inviting women over 18 years old to participate in our survey to help us better understand their motivations and concerns when it comes to undergoing breast cancer screenings.

Participate