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 个研究点目标入组 50 人开始时间: 2009年5月28日最近更新: 2021年8月30日

试验速览

暂无简介。

•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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

发起方

Charité Campus Mitte, Instituts für Radiologie