Actively Recruiting

Age: 18Years +
FEMALE
NCT06498388

Predicting Breast Cancer With the BRAVE System

Led by Université de Sherbrooke · Updated on 2025-02-10

300

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

Sponsors

U

Université de Sherbrooke

Lead Sponsor

C

Cancer Research Society

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Predicting Breast Cancer With the BRAVE System

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • Able and willing to provide signed informed consent in French or English
  • Had a mammogram within the last 6 months
  • Have a newly identified breast mass found by palpation, mammography, sonography, or MRI and referred for more imaging or evaluation
  • Group 1: Breast density category A or B (normal mammographic breast density)
  • Group 2: Breast density category C or D (elevated mammographic breast density)
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Have breast implants or previous breast surgery or biopsy
  • Have any disease or condition that limits ability to complete the examination
  • Have had any previous or ongoing treatment for cancer

AI-Screening

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Trial Site Locations

Total: 1 location

1

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, Canada, J1H5N4

Actively Recruiting

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Research Team

A

Amelie Tetu, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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