New method for detecting breast cancer using the BRAVE system
Official title: Building the Predictive Model of the BRA-based ViscoElastography (BRAVE) System for Detecting Breast Cancer Tumors (BRAVE Discovery Study)
Run by Université de Sherbrooke · NCT06498388 · Data updated 2026-11-12
This study is testing a new way to detect breast cancer using a special method that doesn't involve X-rays or compression, and it's for women who need follow-up imaging.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | Université de Sherbrooke Academic / other |
| Locations | 1 site (Sherbrooke, Quebec) |
| Status | Recruiting |
| Started | January 28, 2025 |
| Main results expected | September 30, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT06498388 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older with a recent mammogram and a newly identified breast mass requiring further evaluation.
✕Probably not a fit
Patients who are pregnant, breastfeeding, have breast implants, or have undergone prior breast surgery or treatment for cancer may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the BRAVE method, which utilizes visco-elastography to detect breast cancer without X-rays or compression. The study will involve 300 women who require follow-up imaging, divided into two groups based on breast density. Participants will undergo a single 75-minute examination while wearing a specialized bra, and data will be collected to assess the method's sensitivity and specificity in identifying malignant lesions. The study also aims to understand how breast density impacts the effectiveness of the BRAVE method.
Why it matters
Potential benefit: If successful, this method could provide a more comfortable and effective way to detect breast cancer, especially in women with dense breast tissue.
How similar studies have gone: While mammography remains the standard, the BRAVE method represents a novel approach that has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Elijah Van Houten, PhD, ing. — Université de Sherbrooke
- Study coordinator: Amelie Tetu, MSc
- Email: amelie.tetu.ciussse-chus@ssss.gouv.qc.ca
- Phone: 819-346-1110
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.