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Screening Contrast-enhanced Mammography

L

Laval University

Status

Enrolling

Conditions

Breast Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT05390229
2019-4432

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Jean-Charles Hogue

Data sourced from clinicaltrials.gov

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