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Clinical Value of 18F-Ethylcholine-PET Combined With Endorectal MRI for Pre-Therapeutic Staging of Prostate Cancer (FEC-PET/MRI)

This study is currently recruiting participants.
Verified by German Federal Armed Forces, January 2008

Sponsored by: 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 III

MedlinePlus related topics:   Cancer    MRI Scans    Prostate Cancer   

ChemIDplus related topics:   Choline    Choline bitartrate    Choline chloride    Choline dihydrogen citrate    Choline salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Open Label, Single Group Assignment, Efficacy Study
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

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 3,3MBq 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 approx. 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
  • asthma bronchiale
  • cardiac pacemaker
  • each kind of 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, Baden-Württemberg
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


Responsible Party:   Institute of Radiobiology of the GFAF ( Dr. Markus Hartenbach )
Study ID Numbers:   12K3-S-140708, EudraCT-Number: 2006-003933-33
First Received:   August 23, 2007
Last Updated:   January 9, 2008
ClinicalTrials.gov Identifier:   NCT00520546
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

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

Study placed in the following topic categories:
Choline
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 10, 2008




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