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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Markus Hartenbach, German Federal Armed Forces
ClinicalTrials.gov Identifier:
NCT00520546
First received: August 23, 2007
Last updated: June 3, 2012
Last verified: June 2012
History of Changes
Results First Received: July 20, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Prostate Cancer
Interventions: Other: 18F-Ethylcholine Positron Emission Tomography (FEC-PET)
Other: Endorectal Magnetic Resonance Imaging (1.5Tesla) (eMRI)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment of first patient: 18th. December, 2007 Completion by last patient: 12th. January, 2011 Single Center Study at Federal Armed Forces Hospital Ulm

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
44 patients were enrolled, 38 patients completed the study. 1 patient decided not to choose prostatectomy after Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI), although it was planned at point of enrollment. 5 patients did not get a PET/MRI-can because of failed radiopharmaceutical synthesis of [18F]fluoroethylcholine (FEC).

Reporting Groups
  Description
FEC-PET/eMRI The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.

Participant Flow:   Overall Study
    FEC-PET/eMRI  
STARTED     44  
COMPLETED     38  
NOT COMPLETED     6  
Withdrawal by Subject                 1  
failed radiopharmaceut. synthesis of FEC                 5  



  Baseline Characteristics
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Reporting Groups
  Description
FEC-PET/eMRI The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.

Baseline Measures
    FEC-PET/eMRI  
Number of Participants  
[units: participants]
 		  44  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     23  
>=65 years     21  
Age  
[units: years]
Mean ± Standard Deviation 		  65  ± 6  
Gender  
[units: participants]
 		 
Female     0  
Male     44  
Region of Enrollment  
[units: participants]
 		 
Germany     44  



  Outcome Measures
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1.  Primary:   Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings   [ Time Frame: within < 2 weeks after PET/MRI ]
  Show Outcome Measure 1

2.  Secondary:   Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in All Patients   [ Time Frame: within < 2 weeks after PET/MRI ]
  Show Outcome Measure 2

3.  Secondary:   Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Gleason Score >6 (3+3)   [ Time Frame: within < 2 weeks after PET/MRI ]
  Show Outcome Measure 3

4.  Secondary:   Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Malignant Lesions >5mm (n=98)   [ Time Frame: within < 2 weeks after PET/MRI ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Major Medical Corps Dr. Markus Hartenbach
Organization: German Federal Armed Forces Hospital, Ulm
phone: 0049 731 1710 1851
e-mail: markushartenbach@bundeswehr.org


Publications:


Responsible Party: Dr. Markus Hartenbach, German Federal Armed Forces
ClinicalTrials.gov Identifier: NCT00520546     History of Changes
Other Study ID Numbers: 12K3-S-140708, 2006-003933-33
Study First Received: August 23, 2007
Results First Received: July 20, 2011
Last Updated: June 3, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices