Contrast kinetics in dynamic contrast-enhanced MRI of the breast in patients with histologically proven breast cancers with and without a computer aided detection system.

• Conditions: MRI, CAD, Computer Aided Detection system, breast, Gadobutrol

• Registration Number: NL-OMON22751
• Lead Sponsor: Atrium Medisch Centrum Parkstad

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Other
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

•At least 18 years of age
•Histologically proven breast cancer (BIRADS 5)
•Patients who are willing to undergo study procedures

Exclusion Criteria

•Patients who have previously entered this study
•Patients who are or are suspected in pragnancy or nursery
•Patients with a contraindication for MRI
•Patients who have received any contrast material within 48 hours prior to injection with study or comparator drug.
•Patients who require emergency treatment
•Patients with impaired renal function of CKD stadium 3 and higher (e.g. creatinine clearance < 60ml/ min). In patients with known renal impairment, clearance will be calculated based on serum creatinine level using the Cockroft-Gault formula. Calculation of the clearance must be done before begin of study.
•Patients with known anaphylactoid or anaphylactic reaction to any contrast media

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The initial rate of enhancement, the maximum enhancement, and the percentage decrease in enhancement in the signal intensity-time curves measured at the last time point relative to the maximum enhancement within the first 120 seconds post contrast agent administration will be determined with and without the use of the CAD-system.

Secondary Outcome Measures

Name	Time	Method
Interobserver variability with and without the use of the CAD-system will be determined