MedTrace Logo

Clinical Value of FEC-PET Combined With Endorectal MRI for Pre-therapeutic Staging of Prostate Cancer

NCT00520546 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-06-20

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

OTHER

18F-Ethylcholine Positron Emission Tomography (FEC-PET)

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.

OTHER

Endorectal Magnetic Resonance Imaging (1.5Tesla) (eMRI)

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.

Sponsors & Collaborators

  • Dr. Markus Hartenbach

    lead OTHER

Principal Investigators

  • Markus Hartenbach, Dr. · German Federal Armed Forces Hospital, Ulm, Dep. of Nuclear Medicine

  • Christoph Sparwasser, Prof. Dr. · German Federal Armed Forces Hospital Ulm, Dep. of Urology

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2011-02-28
Completion
2011-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00520546 on ClinicalTrials.gov