Recruiting

BRAVE System

Sponsor:

Université de Sherbrooke

Code:

NCT06498388

Conditions

Breast Mass

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stiffness measurement by visco-elastography

Study Details

Brief 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.

Conditions

Breast Mass

Breast Cancer

Study ID

NCT06498388

Start date

Jan 28, 2025

Status verified date

May, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Normal Mammographic Breast Density (NMBD)

Women with Normal Mammographic Breast Density (NMBD): Each participant will take part in one imaging session, using the BRAVE system.

Elevated Mammographic Breast Density (EMBD)

Women with Elevated Mammographic Breast Density (EMBD): Each participant will take part in one imaging session, using the BRAVE system.

Interventions

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.

Primary outcome measure

  • Stiffness of the breasts [ Time Frame: Once, at recruitment, up to 6 months after mammography ]
  • Risk and malignancies lesions (RnMLs) [ Time Frame: At the time of mammogram, which will be no more than 6 months prior to recruitment ]

Central Contacts and Locations

Central contacts

Amelie Tetu, MSc

819-346-1110amelie.tetu.ciussse-chus@ssss.gouv.qc.ca

Locations

CIUSSS de l'Estrie - CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H5N4

Principal Investigator:

Elijah Van Houten, PhD, ing.

More Information

Sponsor

Université de Sherbrooke

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • Breast mass
  • Breast cancer
  • Mammogram
  • Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2026-06-01.