Screening Contrast-enhanced Mammography

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT05390229
• Lead Sponsor: CHU de Quebec-Universite Laval

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-12
• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic value for breast cancer	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	Breast cancer screening	To determine the ability of diagnostic imaging to identify other breast masses suspicious of cancer.

Trial Locations

Locations (1)

St-Sacrement Hospital; 🇨🇦 Quebec City, Quebec, Canada