Predicting Breast Cancer With the BRAVE System

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversité de Sherbrooke

About this trial

Breast cancer predominates among cancer diagnoses in Canadian women. It accounts for around 25% of new cases and contributes to 13% of all cancer-related deaths. In 2020, almost 27,400 Canadian women were diagnosed with breast cancer and 5,000 of them died from it.

Mammography is still the preferred method for screening for breast cancer. Although progress has been made over the years, mammography does have its drawbacks. These include physical discomfort for patients, exposure to X-rays and reduced effectiveness in dense breasts. The study team is therefore interested in developing a new breast cancer detection method, the BRAVE method.

The BRAVE method, short for "BRA-based Visco-Elastography", uses the high contrast of elastic stiffness in malignant breast tumors to detect possible cancer cases without the need for X-rays or breast compression.

The first phase, carried out on a small scale pilot study, aimed to assess the method's ability to distinguish a breast with no abnormalities from one with confirmed cancer. The second phase (current phase), carried out on a larger scale, aims to confirm the sensitivity and specificity of the method in detecting malignant lesions, i.e. to determine whether the method is capable of distinguishing between several types of breast masses.

Eligibility criteria

Qualifiers

≥18 years old

Able and willing to provide signed informed consent in French or English

Recent mammogram (< 6 months)

Breast mass newly identified by palpation, mammography, sonography, or MRI and have been referred for additional imaging or evaluation.

Disqualifiers

Pregnant or breast-feeding women

Breast implants or prior surgery/biopsy to breasts

Any disease or condition limiting the capacity to complete the examination process

Any previous or prescribed treatment against cancer

Trial design

Treatments tested in this trial

  • Stiffness measurement by visco-elastography

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Université de Sherbrooke

Lead sponsor

Cancer Research Society

Collaborator