Phase III, Multicenter, Double-blind, Randomized, Crossover Study to Compare MultiHance with Magnevist in Contrast-Enhanced Magnetic Resonance Imaging (MRI) of the Breast.

Phase 3

Completed

Conditions: breastcancer
mammacarcinoma
10006291

Registration Number: NL-OMON30924

Lead Sponsor: Bracco-Byk

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

written Informed Consent
Female subject of 18 years or older
At least one suspicious or known breast lesion
Is planned to undergo histological diagnosis of breast lesions

Exclusion Criteria

Subject:
-has body weight > 100 Kg
-is pregnant or lactating
-has severe or end-stage organ failure
-has moderate to severe renal impairment
-is undergoing or has undergone radiotherapy within 18 months before exam 1
-is undergoing or has undergone chemotherapy/antitumural hormonal therapy within 6 months before exam 1
-has recieved or scheduled to receive any onther contrast medium 24 hours before or after exam1
-has history of breast surgery

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Diagnostic performance of MULTIHANCE and MAGNEVIST will be evaluated by<br /><br>comparing the off-site evaluation results of MRI with the truth standard<br /><br>findings. Sensitivity, specificity, accuracy, positive predictive value and<br /><br>negative predictive value of breast MRI performed with MULTIHANCE or MAGNEVIST<br /><br>will be analyzed independently against the truth standard findings at lesion,<br /><br>region, breast and subject levels. The primary endpoint of this study will be<br /><br>sensitivity with the hypothesis of superiority of MULTIHANCE over MAGNEVIST for<br /><br>breast MRI in the diagnosis of breast cancer. Only lesions confirmed as<br /><br>malignant by histopathology will contribute to the primary analysis. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Measures of diagnostic performance for each MRI examination will also be<br /><br>calculated at region, breast and subject levels and compared as secondary<br /><br>endpoints. </p><br>