Photodynamische Diagnostik mit 5-Aminolävulinsäure zur Beurteilung der intraoperativen Absetzungsränder im Rahmen der radikalen Prostatovesikulektomie bei Patienten mit einem Prostatakarzinom - Photodynamische Diagnostik beim Prostatakarzinom mit 5-ALA
- Conditions
- Patients with prostate carinoma who will undergo radical prostatectomy.MedDRA version: 9.1Level: LLTClassification code 10036921Term: Prostate carcinoma
- Registration Number
- EUCTR2005-004406-93-DE
- Lead Sponsor
- Klinikum der Universität München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Patients with histologically proven prostate caricinoma.
Indication for radical prostatectomy.
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
Renal insufficiency.
Porphyria or allergy to porphyrines.
Hepatic insufficiency.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Intraoperative investigation of surgical margins for residual tumor.;Secondary Objective: Practicability of PDD in the open vs. laparoscopic/extraperitoneal endoscopic operation technique.<br>PPIX-accumulation in tumors of different differentiation grade.;Primary end point(s): Absence or adsence of fluorescence in positive or negative surgical margins, as well as concordance of fluorescing areas with histological findings.
- Secondary Outcome Measures
Name Time Method