RecruitingNCT05390229

Screening Contrast-enhanced Mammography

Comparison of the Performance of Diagnostic Contrast-enhanced Mammography and Magnetic Resonance Imaging for Suspicious Breast Lesion At Screening


Sponsor

CHU de Quebec-Universite Laval

Enrollment

300 participants

Start Date

Dec 12, 2018

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

  • Female aged 18 and over
  • At least one breast lesion with BIRADS classification 5

Exclusion Criteria7

  • 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

Locations(1)

St-Sacrement Hospital

Québec, Quebec, Canada

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NCT05390229


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