Clinical trial NCT06498388: Predicting Breast Cancer With the BRAVE System
Official title: Building the Predictive Model of the BRA-based ViscoElastography (BRAVE) System for Detecting Breast Cancer Tumors (BRAVE Discovery Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Mass
Breast Cancer
Keywords: Breast mass
Breast cancer
Mammogram
Imaging
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Cancer Research Society
First posted: 2024-07-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 ≥18 years old women with a recent mammogram and a reference for additional imaging or evaluation

Brief 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.

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.

1. To measure the sensitivity and specificity of BRAVE in identifying malignant lesions in a cohort of 300 women.
2. 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.

Eligibility 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

Primary outcomes:
measure: Stiffness of the breasts
timeFrame: Once, at recruitment, up to 6 months after mammography
measure: Risk and malignancies lesions (RnMLs)
timeFrame: At the time of mammogram, which will be no more than 6 months prior to recruitment
Secondary outcomes:
measure: Breast density
timeFrame: Once, at mammogram (up to 6 months prior to recruitement)
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Elijah Van Houten, PhD, ing.
role: PRINCIPAL_INVESTIGATOR
References: