Screening Contrast-enhanced Mammography

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

St-Sacrement Hospital

Québec, Quebec, G1S4L8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2025
Study completion: 2025
First posted: May 25, 2022
Registry last updated: Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed