Predicting Breast Cancer With the BRAVE System

Recruiting now

Conditions studied: Breast Mass, Breast Cancer

In brief

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.

Key facts

Study ID

NCT06498388

Run by

Université de Sherbrooke

People needed

300

Starts

2025-01-28

Expected to finish

2028-12-31

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• ≥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.
• Specific inclusion Criteria:
• Group 1 - Normal Mammographic Breast Density (NMBD): Breast density A or B Group 2 - Elevated Mammographic Breast Density (EMBD): Breast density C or D

You may not qualify if…

• 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

Where it is running

• CIUSSS de l'Estrie - CHUS — Sherbrooke, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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