Breast Cancer Clinical Trial
Official title:
Comparison of the Performance of Diagnostic Contrast-enhanced Mammography and Magnetic Resonance Imaging for Suspicious Breast Lesion at Screening
NCT number | NCT05390229 |
Other study ID # | 2019-4432 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 12, 2018 |
Est. completion date | December 2024 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | St-Sacrement Hospital | Quebec City | Quebec |
Lead Sponsor | Collaborator |
---|---|
CHU de Quebec-Universite Laval |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic value for breast cancer | To measure sensitivity, specificity, positive predictive value and negative predictive value for CESM and MRI using histopathological confirmation as a standard value. | Breast cancer screening | |
Primary | Diagnostic value for suspicious breast lesion | To determine the ability of diagnostic imaging to identify other breast masses suspicious of cancer. | Breast cancer screening |
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