Clinical trial · Observational
Predicting Breast Cancer With the BRAVE System
Building the Predictive Model of the BRA-based ViscoElastography (BRAVE) System for Detecting Breast Cancer Tumors (BRAVE Discovery Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Mass | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stiffness measurement by visco-elastography | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Normal Mammographic Breast Density (NMBD)
- description
- Women with Normal Mammographic Breast Density (NMBD): Each participant will take part in one imaging session, using the BRAVE system.
- interventionNames
- Other: Stiffness measurement by visco-elastography
- label
- Elevated Mammographic Breast Density (EMBD)
- description
- Women with Elevated Mammographic Breast Density (EMBD): Each participant will take part in one imaging session, using the BRAVE system.
- interventionNames
- Other: Stiffness measurement by visco-elastography
Primary outcomes (2)
- measure
- Stiffness of the breasts
- timeFrame
- Once, at recruitment, up to 6 months after mammography
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available