Trials / Completed
CompletedNCT05390229
Screening Contrast-enhanced Mammography
Comparison of the Performance of Diagnostic Contrast-enhanced Mammography and Magnetic Resonance Imaging for Suspicious Breast Lesion at Screening
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 231 (actual)
- Sponsor
- CHU de Quebec-Universite Laval · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The main objective of this study is to compare the diagnostic performance of two diagnostic methods, namely CESM and MRI, in the evaluation of a lesion suspicious of breast cancer in 300 Quebec women referred for the investigation of breast cancer. breast lesion suspected of cancer. All suspicious lesions will be evaluated by these two diagnostic imaging and by TNM. Then, radiologists will respectively interpret diagnostic imaging, without knowing the result of the other imaging in parallel with the study. The sensitivity, specificity, positive predictive value and negative predictive value for his diagnostic imaging will then be determined. Histopathological confirmation by biopsy or surgery will be used as a standard value.
Conditions
Timeline
- Start date
- 2018-12-12
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2022-05-25
- Last updated
- 2026-03-19
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT05390229. Inclusion in this directory is not an endorsement.