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NCT Number: NCT06498388

Predicting Breast Cancer With the BRAVE System

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.

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Key information

Conditions

Breast Mass Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, J1H5N4, Canada

Location status: Recruiting

Location contact

Elijah Van Houten, PhD, ing.

PRINCIPAL_INVESTIGATOR

About this study

This study has two objectives, which will be studied in two separate groups.

  • To measure the sensitivity and specificity of BRAVE in identifying malignant lesions in a cohort of 300 women.
  • To assess the impact of breast density on the ability of BRAVE to discriminate malignant breast lesions.

The research team aim to recruit 300 women requiring follow-up imaging. Half will have lower breast density (categories A or B) and the other half will have higher breast density (categories C or D).

Participants will need to attend a single visit lasting approximately 75 minutes, where they will be asked to wear the study's bra and complete the examination process.

Other data will also be collected in the medical file to enable the team to confirm: the density of the breast, and the results and dates of mammography imaging or other tests related to breast cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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

Exclusion criteria

  • 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

Treatment and study plan

Stiffness measurement by visco-elastography

Other

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.

Primary outcomes

  1. Stiffness of the breasts

    Time frame: 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.

  2. Risk and malignancies lesions (RnMLs)

    Time frame: 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.

Secondary outcomes

  1. Breast density

    Time frame: Once, at mammogram (up to 6 months prior to recruitement)

    The breast density can be scored as A: low-density, B: few areas of dense tissue, C: evenly dense, D: extremely dense, and is determined by standard of care imaging. Participants will be gathered in either NMBD group (A or B; normal density) or EMBD group (C or D, elevated density).

Study contacts

Contact information is provided by the study sponsor or research team.

Amelie Tetu, MSc

CONTACT

[email protected]

819-346-1110

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Cancer Research Society

Registry information

Official study title

Building the Predictive Model of the BRA-based ViscoElastography (BRAVE) System for Detecting Breast Cancer Tumors (BRAVE Discovery Study)

Acronym: BRAVE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 12, 2024
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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