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Clinical Trials/EUCTR2009-009476-12-DE
EUCTR2009-009476-12-DE
Active, Not Recruiting
Phase 1

on-invasive detection of prostate cancer using functional MRI in patients with histopathologically confirmed prostate cancer before prostatectomy - Functional MRI in Prostate Cancer

Charité Campus Mitte, Instituts für Radiologie0 sites50 target enrollmentMay 28, 2009
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DrugsGadovist® 1.0 mmol/ml contrast medium

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Charité Campus Mitte, Instituts für Radiologie
Enrollment
50
Status
Active, Not Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 28, 2009
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
Charité Campus Mitte, Instituts für Radiologie

Eligibility Criteria

Inclusion Criteria

  • •1\.Age: 18\-85 years
  • •2\.First diagnosis of prostate cancer from histopathological examination of biopsy
  • •3\.Scheduled for prostatectomy not earlier than 4 weeks after prostate biopsy for
  • •clinical reasons
  • •4\.Willing to comply with the study procedures
  • •5\.Patients who have given their fully informed, written and dated consent voluntarily
  • •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

Exclusion Criteria

  • •1\.Having an underlying disease or concomitant medication which may interfere with
  • •efficacy or safety evaluations as planned in this study
  • •2\.GFR \<60ml/m²/1\.73m² (MDRD or Cockroft\-Gault formula), creatiine values \=1 week
  • •3\.Not being able to remain lying down for at least 45\-60 min (e.g., patients with
  • •unstable angina, dyspnea at rest, severe pain at rest, severe back pain)
  • •4\.Known allergy to any ingredient of Gadovist
  • •5\.Presenting with history of anaphylactoid or anaphylactic reaction to any allergen
  • •including drugs and contrast agents
  • •6\.Being clinically unstable
  • •7\.Having any contraindication to MRI examination or specifically to MRV (e.g.,

Outcomes

Primary Outcomes

Not specified

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