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

Phase 1

• Conditions: Prostata cancer; MedDRA version: 9.1Level: LLTClassification code 10007113Term: Cancer of prostate

• Registration Number: EUCTR2009-009476-12-DE
• Lead Sponsor: Charité Campus Mitte, Instituts für Radiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-28
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

1.Age: 18-85 years
2.First diagnosis of prostate cancer from histopathological examination of biopsy
specimens
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 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.,
pacemaker, recent wound clips, and severe claustrophobia).
8.Having any physical or mental status that interferes with the informed consent
procedure including self-signed consent
9.Close affiliation with the investigational site; e.g. a close relative of the
investigator
10.Having been previously enrolled in this study
11.Participating in another clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified