Clinical Value of FEC-PET Combined With Endorectal MRI for Pre-therapeutic Staging of Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 18F-Ethylcholine Positron Emission Tomography (FEC-PET); Endorectal Magnetic Resonance Imaging (1.5Tesla) (eMRI)
Intervention description: PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a "cold" transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. After a short gap due to computer processing time the whole body scan was performed starting at the upper thoracic aperture down to the proximal femur. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure.; The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2 weighted (T2w) turbo spin echo (TSE) transversal and a coronal short-tau inversion recovery (STIR) sequence. For prostate assessment, 3mm endorectal T2w spin echo (SE) sagittal, transversal and coronal sequences were acquired.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No
Keywords: PET; MRI; Choline; FEC; prostate cancer

Summary:

      To investigate the sensitivity of the [18F]fluoroethylcholine (FEC)
      Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) method in tumour detection
      and location (side assignment, encapsulation, invasion of the seminal vesicle) and detection
      of affected lymph nodes, and to compare these with presently used detection procedures
      (needle biopsy, digital rectal examination, transrectal ultrasound, and pre-therapeutic
      assessment), with a view to finding out whether the [18F]fluoroethylcholine PET/MRI method is
      comparable to, or superior to, the established method. Postoperative histology served as the
      standard of reference.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically diagnosed prostate cancer (needle biopsy)

          -  Radical prostatectomy as primary treatment

          -  No nutrition within 12 hours before Positron-Emission-Tomography (PET)

          -  No food containing choline within 24 hous before PET

          -  Age > 50 years

        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

          -  Claustrophobia

          -  Medical drugs with choline

          -  Severe liver damage

          -  Cardiac infarction

          -  Bradycardia (pulse rate < 55/min)

          -  Allergic reaction against Neurotropan

          -  Bronchial asthma

          -  Cardiac pacemaker

          -  Small metal implants (e.g., clips, cochlea-implants, etc.)