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:
Dr. Markus Hartenbach
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
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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.
|
Show Detailed Description 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
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:
| 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 Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013