New method for detecting breast cancer using the BRAVE system
Building the Predictive Model of the BRA-based ViscoElastography (BRAVE) System for Detecting Breast Cancer Tumors (BRAVE Discovery Study)
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Université de Sherbrooke Academic / other |
| Locations | 1 site (Sherbrooke, Quebec) |
| Trial ID | NCT06498388 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a recent mammogram and a newly identified breast mass requiring further evaluation.
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.
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 performed: While mammography remains the standard, the BRAVE method represents a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
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 this trial is running
Sherbrooke, Quebec
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.