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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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.

⁃ Group 1 - Normal Mammographic Breast Density (NMBD): Breast density A or B Group 2 - Elevated Mammographic Breast Density (EMBD): Breast density C or D

Locations
Other Locations
Canada
CIUSSS de l'Estrie - CHUS
RECRUITING
Sherbrooke
Contact Information
Primary
Amelie Tetu, MSc
amelie.tetu.ciussse-chus@ssss.gouv.qc.ca
819-346-1110
Time Frame
Start Date: 2025-01-28
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 300
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Université de Sherbrooke
Collaborators: Cancer Research Society

This content was sourced from clinicaltrials.gov