Breast MassBRAVENCT06498388
Predicting Breast Cancer With the BRAVE System
An observational study of Breast Mass and Breast Cancer, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Mass, Breast Cancer
- What is being tested?
- Stiffness measurement by visco-elastography
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jan 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 300 ≥18 years old women with a recent mammogram and a reference for additional imaging or evaluation
Who may be able to join
- ≥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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, J1H5N4
Elijah Van Houten, PhD, ing.
About this study
Official title: Building the Predictive Model of the BRA-based ViscoElastography (BRAVE) System for Detecting Breast Cancer Tumors (BRAVE Discovery Study)
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.
Read more
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.
Read the detailed description
This study has two objectives, which will be studied in two separate groups.
- To measure the sensitivity and specificity of BRAVE in identifying malignant lesions in a cohort of 300 women.
- To assess the impact of breast density on the ability of BRAVE to discriminate malignant breast lesions.
The research team aim to recruit 300 women requiring follow-up imaging. Half will have lower breast density (categories A or B) and the other half will have higher breast density (categories C or D).
Participants will need to attend a single visit lasting approximately 75 minutes, where they will be asked to wear the study's bra and complete the examination process.
Other data will also be collected in the medical file to enable the team to confirm: the density of the breast, and the results and dates of mammography imaging or other tests related to breast cancer.
- Conditions
- Breast Mass, Breast Cancer
- Being tested
- Stiffness measurement by visco-elastography
- Keywords
- Breast mass, Breast cancer, Mammogram, Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stiffness measurement by visco-elastographyOther
Participant 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Stiffness measurement by visco-elastography | |
| 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. Receives: Other: Stiffness measurement by visco-elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once, at recruitment, up to 6 months after mammography
Risk and malignancies lesions (RnMLs)
Defined by mammography, additional imaging and biopsy results and scored as BI-RADS 5 to 6.
Measured: At the time of mammogram, which will be no more than 6 months prior to recruitment
Secondary 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).
Measured: Once, at mammogram (up to 6 months prior to recruitement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start28 Jan 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast MassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research Society
- Responsible party
- Sponsor
- Investigators
- Elijah Van Houten, PhD, ing., Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498388
- Sponsor's protocol ID
- 2024-5453
- Acronym
- BRAVE
- Status last verified
- May 2026
- First submitted
- 3 Jun 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building the Predictive Model of the BRA-based ViscoElastography (BRAVE) System for Detecting Breast Cancer Tumors (BRAVE Discovery Study)
- ClinicalTrials.gov ID
- NCT06498388
- Acronym / sponsor ID
- BRAVE / 2024-5453
- Conditions
- Breast Mass, Breast Cancer
- Keywords
- Breast mass, Breast cancer, Mammogram, Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Cancer Research Society
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study has two objectives, which will be studied in two separate groups.
- To measure the sensitivity and specificity of BRAVE in identifying malignant lesions in a cohort of 300 women.
- To assess the impact of breast density on the ability of BRAVE to discriminate malignant breast lesions.
The research team aim to recruit 300 women requiring follow-up imaging. Half will have lower breast density (categories A or B) and the other half will have higher breast density (categories C or D).
Participants will need to attend a single visit lasting approximately 75 minutes, where they will be asked to wear the study's bra and complete the examination process.
Other data will also be collected in the medical file to enable the team to confirm: the density of the breast, and the results and dates of mammography imaging or other tests related to breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Mammographic Breast Density (NMBD) | – | Other: Stiffness measurement by visco-elastographyWomen with Normal Mammographic Breast Density (NMBD): Each participant will take part in one imaging session, using the BRAVE system. |
| Elevated Mammographic Breast Density (EMBD) | – | Other: Stiffness measurement by visco-elastographyWomen with Elevated Mammographic Breast Density (EMBD): Each participant will take part in one imaging session, using the BRAVE system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 ≥18 years old women with a recent mammogram and a reference for additional imaging or evaluation
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stiffness measurement by visco-elastographyParticipant 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. | Other | Elevated Mammographic Breast Density (EMBD), Normal Mammographic Breast Density (NMBD) |
Primary outcome
Stiffness of the breasts
Time frame: Once, at recruitment, up to 6 months after mammography
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.
Risk and malignancies lesions (RnMLs)
Time frame: At the time of mammogram, which will be no more than 6 months prior to recruitment
Defined by mammography, additional imaging and biopsy results and scored as BI-RADS 5 to 6.
1 secondary outcome
Breast density
Time frame: Once, at mammogram (up to 6 months prior to recruitement)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elijah Van Houten, PhD, ing. principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Mass and Breast Cancer, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelie Tetu, MSc (819-346-1110, amelie.tetu.ciussse-chus@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stiffness of the breasts (time frame: Once, at recruitment, up to 6 months after mammography). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.