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Clinical Trials/NL-OMON30924
NL-OMON30924
Completed
Phase 3

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

Bracco-Byk0 sites40 target enrollmentTBD

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
breastcancer
Sponsor
Bracco-Byk
Enrollment
40
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Bracco-Byk

Eligibility Criteria

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

  • \-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

Outcomes

Primary Outcomes

Not specified

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