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Clinical Trials/EUCTR2010-018862-22-DE
EUCTR2010-018862-22-DE
Active, not recruiting
Not Applicable

Exploratory study to evaluate different MRI-contrast-agent-application-schemes using Gadovist to optimize contrast enhancement for longer lasting breast examination - Contrast agent application scheme

Kliniken Essen-Mitte0 sites50 target enrollmentJune 9, 2010
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ConditionsPatients with recent diagnosis of breast cancer, histologically proven.MedDRA version: 12.1Level: LLTClassification code 10006187Term: Breast cancer
DrugsGadovist

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients with recent diagnosis of breast cancer, histologically proven.
Sponsor
Kliniken Essen-Mitte
Enrollment
50
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 9, 2010
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Kliniken Essen-Mitte

Eligibility Criteria

Inclusion Criteria

  • •1\) Adult patients, age 18 years and older
  • •2\) with recent diagnosis of breast cancer, histologically proven (within the last 6 weeks before inclusion)
  • •3\) referred to contrast\-enhanced MRI of the breast for clinical reasons before surgery
  • •4\) willing and able to comply with and complete all study procedures
  • •5\) who provided written informed consent voluntarily and in person
  • •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

Exclusion Criteria

  • •1\) If female, being pregnant or in nursery (females of childbearing potential must have a negative urine pregnancy test at the day of MRI prior to administration of gadobutrol
  • •2\) Any contraindication to the MRI procedure (e.g., metal implants, phobia)
  • •3\) Any contraindication to gadolinium\-containing MR contrast agents
  • •4\) History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
  • •5\) Having received any contrast agent within 24 hours prior to the MRI examination planned in this study
  • •6\) Considered to be clinically unstable or risk of unpredictable clinical course during the study period (e.g., due to previous surgery, acute renal failure)
  • •7\) Severe cardiovascular disease (e.g., known long QT syndrome, acute myocardinal infraction \[\<14 days], unstable angina, congestive heart failure NYHA class IV) or acute stroke (\<48 hours)
  • •8\) Severly or moderately impaired renal function (GFR calculated with MDRD formular 9\) Scheduled or likely to require surgery and/ or biopsy before MRI or within 24 hours after study drug administration
  • •10\) Participating in another diagnostic clinical trial
  • •11\) Having previously entered this study

Outcomes

Primary Outcomes

Not specified

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