Clinical value of Choline-Positron-Emission-Tomography combined with Magnetic Resonance Imaging by software fusion for pre-therapeutic staging of prostate cancer

• Conditions: Clinical value of Choline-Positron-Emission-Tomography combined with Magnetic Resonance Imaging by software fusion for pre-therapeutic staging of prostate cancer referring to histopathological, postoperative results

• Registration Number: EUCTR2006-003933-33-DE
• Lead Sponsor: Bundeswehr

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

- preoperative suspected prostate cancer (e.g. suspect digital rectal examination and/or PSA-Level >10,0 ng/ml)
- radical prostatectomy as primary treatment
- no nutrition within 12 hours before PET
- no food containing choline within 24 hous before PET
- age >50 years
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

- total endo-prothesis of the hip region
- clinical or chemical detection of an acute infection
- missing patient agreement
- secondary cancer
- surgical treatment within 3 month before PET
- claustrophoby
- medical drugs with choline
- severe liver damage
- cardiac infarction
- Bradycardie (pulserate<55/min)
- allergic reaction against Neurotropan
- asthma bronchiale
- cardiac pacemaker
- each kind of small metall implants (e.g. clips, cochlea-implants, etc.)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Clinical value of Choline-Positron-Emission-Tomography combined with Magnetic Resonance Imaging by software fusion for pre-therapeutic staging of prostate cancer referring to histopathological, postoperative results;Secondary Objective: Is there a significant difference between benign intraprostatic lesions and prostate cancer concerning dynamic and static uptake pattern of 18F-choline and do the study results correlate with other clinical data such as PSA-levels, TRUS-results, etc.;Primary end point(s): The clinical trial will end after inclusion and operative intervention of >=43 patients with prostate cancer before radical prostatectomy.