Predicting Breast Cancer With the BRAVE System

Condition(s) studied

Investigational drug(s) / intervention(s)

Stiffness measurement by visco-elastography: Participant will be asked to put on the study's bra with the help of a female member of the team if necessary and to complete the examination process.

Study summary

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

Primary outcome measure(s)

• Stiffness of the breasts — Once, at recruitment, up to 6 months after mammography
  Main marker that will be assessed for its capacity to identify malignant lesions. It will be measured by the viscoelastic property values determined by the BRAVE system.
• Risk and malignancies lesions (RnMLs) — At the time of mammogram, which will be no more than 6 months prior to recruitment
  Defined by mammography, additional imaging and biopsy results and scored as BI-RADS 5 to 6.

Trial sites (1)

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