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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
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Other: 18F-Ethylcholine Positron Emission Tomography (FEC-PET)
Other: Endorectal Magnetic Resonance Imaging (1.5Tesla) (eMRI)
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 [18]Fluoroethylcholine Positron-Emission-Tomography Combined With Endorectal 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:
  • 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 ] [ Designated as safety issue: No ]
    PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. At least 1 histological confirmed cancer lesion has to be detected by each of the 3 methods to be patient based true positive.


Secondary Outcome Measures:
  • Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in All Patients [ Time Frame: within < 2 weeks after PET/MRI ] [ Designated as safety issue: No ]
    PET positive lesions (n=128) were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative and positive predictive values were determined.

  • 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 ] [ Designated as safety issue: No ]
    PET positive lesions in patients with Gleason >6(3+3),n=43 were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative & positive predictive values were determined.

  • 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 ] [ Designated as safety issue: No ]
    PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative and positive predictive values were determined without malign lesions <=5mm.


Enrollment: 44
Study Start Date: December 2007
Study Completion Date: June 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients with prostate carcinoma confirmed by needle biopsy, age >50 years, planned radical prostatectomy with lymph-node dissection, fasting for >12 hours before FEC-PET and an interval between biopsy and PET >3 weeks.
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.

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  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 Positron-Emission-Tomography (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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00520546

Locations
Germany
German Federal Armed Forces Hospital
Ulm, Baden-Württemberg, Germany, D 89081
Sponsors and Collaborators
Dr. Markus Hartenbach
Investigators
Principal Investigator: Markus Hartenbach, Dr. German Federal Armed Forces Hospital, Ulm, Dep. of Nuclear Medicine
Study Director: Christoph Sparwasser, Prof. Dr. German Federal Armed Forces Hospital Ulm, Dep. of Urology
  More Information

Publications:
Gauthier S, Diksic M, Yamamoto L, Tyler J, Feindel WH (1985): Positron emission tomography with [11C]-choline in human subjects. Can J Neurol Sci 12: 214.

Responsible Party: Dr. Markus Hartenbach, Major Medical Corps and assistant medical director of the nuclear medicine department, 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

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

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

ClinicalTrials.gov processed this record on November 20, 2014