Predicting Breast Cancer With the BRAVE System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversité de Sherbrooke
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
≥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.
Disqualifiers
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
Trial population
300 ≥18 years old women with a recent mammogram and a reference for additional imaging or evaluation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Stiffness measurement by visco-elastography
Other interventionParticipant 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Normal Mammographic Breast Density (NMBD)1 intervention
Group B: Elevated Mammographic Breast Density (EMBD)1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Once, at recruitment, up to 6 months after mammography2
Risk and malignancies lesions (RnMLs)
Defined by mammography, additional imaging and biopsy results and scored as BI-RADS 5 to 6.
Time frame
At the time of mammogram, which will be no more than 6 months prior to recruitmentSecondary outcomes
1
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).
Time frame
Once, at mammogram (up to 6 months prior to recruitement)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Université de Sherbrooke
Lead sponsor
Cancer Research Society
Collaborator
Source ClinicalTrials.gov