Predicting Breast Cancer With the BRAVE System (BRAVE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Mass
• Intervention / Treatment: Other: Stiffness measurement by visco-elastography

Detailed Description

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

1. To measure the sensitivity and specificity of BRAVE in identifying malignant lesions in a cohort of 300 women.
2. 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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Amelie Tetu, MSc; Phone Number: 819-346-1110; Email: amelie.tetu.ciussse-chus@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H5N4
      • Recruiting
      • CIUSSS de l'Estrie - CHUS
      • Principal Investigator: Elijah Van Houten, PhD, ing.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

300 ≥18 years old women with a recent mammogram and a reference for additional imaging or evaluation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stiffness of the breasts	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.	Once, at recruitment, up to 6 months after mammography
Risk and malignancies lesions (RnMLs)	Defined by mammography, additional imaging and biopsy results and scored as BI-RADS 5 to 6.	At the time of mammogram, which will be no more than 6 months prior to recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast density	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).	Once, at mammogram (up to 6 months prior to recruitement)

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Cancer Research Society
• Investigators: Principal Investigator: Elijah Van Houten, PhD, ing., Universite de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Imaging; Breast cancer; Mammogram; Breast mass
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2024-5453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No