Comparison of the Performance of Diagnostic Contrast-enhanced Mammography and Magnetic Resonance Imaging for Suspicious Breast Lesion At Screening
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- CHU de Quebec-Universite Laval
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Diagnostic value for breast cancer
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Diagnostic value for breast cancer
Time Frame: Breast cancer screening
To measure sensitivity, specificity, positive predictive value and negative predictive value for CESM and MRI using histopathological confirmation as a standard value.
Diagnostic value for suspicious breast lesion
Time Frame: Breast cancer screening
To determine the ability of diagnostic imaging to identify other breast masses suspicious of cancer.