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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)
This study is currently recruiting participants.
Study NCT00520546   Information provided by German Federal Armed Forces
First Received: August 23, 2007   Last Updated: November 17, 2008   History of Changes

August 23, 2007
November 17, 2008
December 2007
November 2009   (final data collection date for primary outcome measure)
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 ]
Detection of local and distant prostate cancer foci proven by histopathological results [ Time Frame: within <2 weeks after PET/MRI ]
Complete list of historical versions of study NCT00520546 on ClinicalTrials.gov Archive Site
 
 
 
Clinical Value of 18F-Ethylcholine-Positron Emission Tomography (PET) Combined With Endorectal MRI for Pre-Therapeutic Staging of Prostate Cancer
Clinical Value of 18F-Ethylcholine-Positron-Emission-Tomography Combined With Magnetic Resonance Imaging by Software Fusion for Pre-Therapeutic Staging of Prostate Cancer

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.

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).

Phase III
Interventional
Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Prostate Cancer
  • Other: 18F-Ethylcholine Positron Emission Tomography
  • Other: Endorectal Magnetic Resonance Imaging (1.5T)
Other: Patients with histologically diagnosed prostate cancer (by needle biopsy) before surgery (radical prostatectomy).
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
43
December 2009
November 2009   (final data collection date for primary outcome measure)

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.)
Male
50 Years and older
No
Contact: Markus Hartenbach, Doctor +498931683925 markushartenbach@bundeswehr.org
Contact: Burkhard Klemenz, Doctor +498973117101850 burkhardklemenz@bundeswehr.org
Germany
 
NCT00520546
Dr. Markus Hartenbach, Institute of Radiobiology of the GFAF
12K3-S-140708, EudraCT-Number: 2006-003933-33
German Federal Armed Forces
 
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
German Federal Armed Forces
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP