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
Conditions
Interventions
Product Name: [18F]Fluoroethylcholin chlorid
Product Code: FEC
Pharmaceutical Form: Intravenous infusion
CAS Number: 62497
Other descriptive name: CHOLINE
Concentration unit: µg microgram(s)
Concentra
Sponsors
Bundeswehr
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Outcome results
None listed