Assessing a new imaging application for breast tomosynthesis
Clinical Data Collection in Breast Tomosynthesis: COBRIS
This study is testing a new imaging tool during routine mammograms to see if it can improve the detection of breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 35 Years and up |
| Sex | Female |
| Sponsor | GE Healthcare Industry-sponsored |
| Locations | 1 site (Villejuif) |
| Trial ID | NCT05914168 on ClinicalTrials.gov |
What this trial studies
This study evaluates an innovative image acquisition application for breast tomosynthesis in a clinical setting. Participants will undergo their routine mammography examination, with an additional view obtained using the investigational application for analysis. The entire participation process is expected to last no more than 30 minutes, after which subjects will be followed according to standard hospital care protocols. The goal is to enhance the imaging process for better breast cancer detection.
Who should consider this trial
Good fit: Ideal candidates are women aged 35 years or older who are referred for mammography and can provide informed consent.
Not a fit: Patients who are minors, pregnant, or have BRCA 1 or BRCA 2 gene mutations may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved breast cancer detection and diagnosis through enhanced imaging techniques.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving imaging techniques for breast cancer detection.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged 35 years or older; * Women referred for unilateral or bilateral 2D and 3D mammography; * Women able and willing to comply with study procedures; * Women able and willing to participate in this study who have signed and dated the informed consent form; and * Women surgically sterile or postmenopausal or, the possibility of pregnancy is ruled out based on a negative urine pregnancy test Exclusion Criteria: * Women who have been previously included in this study; or * Be a minor, protected adult, adult deprived of liberty by judicial or administrative decision, pregnant, parturient or a breastfeeding mother; or * Women with BRCA 1 or BRCA 2 gene mutation
Where this trial is running
Villejuif
- Gustave Roussy — Villejuif, France (Recruiting)
Study contacts
- Principal investigator: Balleyguier — Gustave Roussy, Cancer Campus, Grand Paris
- Study coordinator: Jean-Paul Antonini
- Email: jean-paul.antonini@ge.com
- Phone: +33 6 87706729
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.