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Clinical Value of 18F-Ethylcholine-Positron Emission Tomography (PET) Combined With Endorectal MRI for Pre-Therapeutic Staging of Prostate Cancer (FEC-PET/MRI)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by German Federal Armed Forces.   Recruitment status was  Recruiting

First Received on August 23, 2007.   Last Updated on November 17, 2008   History of Changes
Sponsor: German Federal Armed Forces
Information provided by: German Federal Armed Forces
ClinicalTrials.gov Identifier: NCT00520546
  Purpose

The aim of this study is the improvement of primary diagnostics of patients with prostate cancer by detecting cancer tissue and metastasis (in lymph nodes and other organs) with Choline-PET/MRI.


Condition Intervention Phase
Prostate Cancer
Other: 18F-Ethylcholine Positron Emission Tomography
Other: Endorectal Magnetic Resonance Imaging (1.5T)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Value of 18F-Ethylcholine-Positron-Emission-Tomography Combined With Magnetic Resonance Imaging by Software Fusion for Pre-Therapeutic Staging of Prostate Cancer

Resource links provided by NLM:


Further study details as provided by German Federal Armed Forces:

Primary Outcome Measures:
  • Detection of local and distant prostate cancer foci proven by histopathological results [ Time Frame: within < 2 weeks after PET/MRI ] [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: December 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Patients with histologically diagnosed prostate cancer (by needle biopsy) before surgery (radical prostatectomy).
Other: 18F-Ethylcholine Positron Emission Tomography
One dosage of 3,3 MBq fluorine-18 ethylcholine intravenous. Measure time: about 60-80 minutes.
Other: Endorectal Magnetic Resonance Imaging (1.5T)
Non-contrast-enhanced MRI with applied endorectal and body-array coil. Measure time: approximately 45 minutes.

Detailed Description:

Choline can be marked by a positron radiator (in this trial 18F) enabling a PET to detect the regional distribution of this substance in high local resolution. Due to the image-fusion of high resolution MRI, accumulations can be assigned exactly with anatomical structures, in order to facilitate a phase-adapted therapeutic treatment.

This study should prove, that Choline-PET/MRI is able to detect prostate cancer with a sensitivity of over 90% (9% accuracy, 95% confidence interval). PET/MRI results of 43 patients with histologically known prostate cancer (needle biopsy) will be correlated to the post-interventional histopathological results (radical prostatectomy).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically diagnosed prostate cancer (needle biopsy)
  • Radical prostatectomy as primary treatment
  • No nutrition within 12 hours before 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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520546

Contacts
Contact: Markus Hartenbach, Doctor +498931683925 markushartenbach@bundeswehr.org
Contact: Burkhard Klemenz, Doctor +498973117101850 burkhardklemenz@bundeswehr.org

Locations
Germany
German Federal Armed Forces Hospital Recruiting
Ulm, Baden-Württemberg, Germany, D 89081
Contact: Burkhard Klemenz, Dr.     +4973117101850     burkhardklemenz@bundeswehr.org    
Sub-Investigator: Burkhard Klemenz, Dr.            
Principal Investigator: Christoph Sparwasser, Prof. Dr.            
Sub-Investigator: Burkhardt Danz, Dr.            
Sponsors and Collaborators
German Federal Armed Forces
Investigators
Study Director: Markus Hartenbach, Dr. Institute of Radiobiology, German Federal Armed Forces, Munich
Principal Investigator: Christoph Sparwasser, Prof. Dr. German Federal Armed Forces Hospital Ulm, Dep. of Urology
Study Chair: Burkhard Klemenz, Dr. German Federal Armed Forces Hospital Ulm, Dep. of Nuclear Medicine
  More Information

No publications provided

Responsible Party: Dr. Markus Hartenbach, Institute of Radiobiology of the GFAF
ClinicalTrials.gov Identifier: NCT00520546     History of Changes
Other Study ID Numbers: 12K3-S-140708, EudraCT-Number: 2006-003933-33
Study First Received: August 23, 2007
Last Updated: November 17, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by German Federal Armed Forces:
PET
MRI
Choline
FEC
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 22, 2012