Predicting Breast Cancer With the BRAVE System

NCT06498388 | Recruiting

• 1 other identifier: 2024-5453
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Mass; Breast Cancer

Keywords

Breast mass; Breast cancer; Mammogram; Imaging

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At the time of mammogram, which will be no more than 6 months prior to recruitment

Secondary Outcomes (1)

• Breast density

  Once, at mammogram (up to 6 months prior to recruitement)

Study Arms (2)

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.

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.

Other: Stiffness measurement by visco-elastography

Interventions

Stiffness measurement by visco-elastography OTHER

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.

Elevated Mammographic Breast Density (EMBD); Normal Mammographic Breast Density (NMBD)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

300 ≥18 years old women with a recent mammogram and a reference for additional imaging or evaluation

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Cancer Research Society: collaborator

Study Sites (1)

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, J1H5N4, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elijah Van Houten, PhD, ing.

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amelie Tetu, MSc

CONTACT

819-346-1110; amelie.tetu.ciussse-chus@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: July 12, 2024
• Study Start: January 28, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)