Screening Contrast-enhanced Mammography

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05390229

Enrollment

231

Registered

2022-05-25

Start date

2018-12-12

Completion date

2025-12-31

Last updated

2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Canada

Outcome results