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Clinical Trials/EUCTR2009-013432-20-DE
EUCTR2009-013432-20-DE
Active, not recruiting
Phase 1

Intra-individual, randomized comparison of the MRI contrast agents gadobutrol versus gadoterate meglumine in breast MR imaging - Gadovist in breast MRI

Charité Campus Mitte0 sites52 target enrollmentJune 22, 2009
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DrugsGadovist 1.0 mmol/mlDotarem 0.5 mmol/ml

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Charité Campus Mitte
Enrollment
52
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 22, 2009
End Date
July 30, 2010
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Charité Campus Mitte

Eligibility Criteria

Inclusion Criteria

  • •Age: 18\-70 years
  • •histologically proven breast tumor or suspected benign and malignant lesions, biopsy performed or planned
  • •willing to undergo all study procedures
  • •having personally signed and dated the informed consent form
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Patients who are in (or are suspected of) pregnancy or nursery. In women of child bearing potential a pregnancy test must be performed before inclusion in this study
  • •Patients with any physical or mental status that interferes with the signing of informed consent
  • •any contraindication for MRI
  • •having received any contrast material within 12 hours prior to injection with study or comparator drug.
  • •requiring 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 or MDRD formula. Calculation of the clearance must be done before begin of study.
  • •Patients who are scheduled for breast surgery or who would have a biopsy prior to the second planned injection of contrast medium
  • •History of anaphylactoid or anaphylactic reaction to any contrast media
  • •Having been previously enrolled in this study

Outcomes

Primary Outcomes

Not specified

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