Comparing two imaging methods for breast cancer diagnosis
Comparison of the Performance of Diagnostic Contrast-enhanced Mammography and Magnetic Resonance Imaging for Suspicious Breast Lesion At Screening
CHU de Quebec-Universite Laval · NCT05390229
This study is testing whether contrast-enhanced mammography or MRI is better at finding breast cancer in women who have suspicious lesions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | CHU de Quebec-Universite Laval (other) |
| Locations | 1 site (Quebec City, Quebec) |
| Trial ID | NCT05390229 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the diagnostic performance of contrast-enhanced mammography (CESM) versus MRI in identifying breast lesions suspected of cancer among 300 women in Quebec. Participants will undergo both imaging techniques, and the results will be interpreted independently by radiologists who are unaware of the other imaging results. The study will assess the sensitivity, specificity, and predictive values of each method, using histopathological confirmation from biopsy or surgery as the standard reference.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and over with at least one breast lesion classified as BIRADS 5.
Not a fit: Patients who are pregnant, have significant kidney failure, or have allergies to contrast media may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of breast cancer diagnosis, leading to better patient outcomes.
How similar studies have performed: Previous studies have shown promising results in comparing imaging techniques for breast cancer diagnosis, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female aged 18 and over * At least one breast lesion with BIRADS classification 5 Exclusion Criteria: * Refusal to perform the biopsy or surgery * Pregnant or possibly pregnant woman * Usual contraindication to contrast product * Significant kidney failure * Allergy to contrast medium * hyperthyroidism * Usual contraindications to MRI
Where this trial is running
Quebec City, Quebec
- St-Sacrement Hospital — Quebec City, Quebec, Canada (RECRUITING)
Study contacts
- Study coordinator: Jean-Charles Hogue
- Email: jean-charles.hogue@crchudequebec.ulabal.ca
- Phone: 4185254444
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.
Conditions: Breast Cancer