Clinical trial · Interventional
Clinical Value of FEC-PET Combined With Endorectal MRI for Pre-therapeutic Staging of Prostate Cancer
Clinical Value of [18]Fluoroethylcholine Positron-Emission-Tomography Combined With Endorectal Magnetic Resonance Imaging by Software Fusion for Pre-therapeutic Staging of Prostate Cancer
NCT00520546CI-TRIAL-00007217FEC-PET/MRIcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-Ethylcholine Positron Emission Tomography (FEC-PET) | Other | — | UNRESOLVED |
| Endorectal Magnetic Resonance Imaging (1.5Tesla) (eMRI) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- 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.
- interventionNames
- Other: 18F-Ethylcholine Positron Emission Tomography (FEC-PET)
- Other: Endorectal Magnetic Resonance Imaging (1.5Tesla) (eMRI)
Primary outcomes (1)
- measure
- Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings
- timeFrame
- within < 2 weeks after PET/MRI
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
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.)
References
Publications (14)
- BACKGROUNDRobert-Koch-Institut (2010): Krebs in Deutschland 2005/2006 Häufigkeiten und Trends. A collaborative publication of the Robert-Koch-Institut and the Gesellschaft der epidemiologischen Krebsregister in Deutschland e.V. [Society for epidemiological cancer register], 7th edition, Berlin.
- BACKGROUNDBörgermann C, Rübben H (2006): Früherkennung des Prostatakarzinoms [Early recognition of prostate carcinoma]. Dtsch Arztebl. 103: 2399-2406.
- BACKGROUNDBreslow N, Chan CW, Dhom G, Drury RA, Franks LM, Gellei B, Lee YS, Lundberg S, Sparke B, Sternby NH, Tulinius H. Latent carcinoma of prostate at autopsy in seven areas. The International Agency for Research on Cancer, Lyons, France. Int J Cancer. 1977 Nov 15;20(5):680-8. doi: 10.1002/ijc.2910200506. PMID 924691
- BACKGROUNDde Jong IJ, Pruim J, Elsinga PH, Vaalburg W, Mensink HJ. Preoperative staging of pelvic lymph nodes in prostate cancer by 11C-choline PET. J Nucl Med. 2003 Mar;44(3):331-5. PMID 12620996
- BACKGROUNDDeutsche Gesellschaft für Urologie (2009): Interdisziplinäre Leitlinie der Qualität S3 zur Früherkennung, Diagnose und Therapie der verschiedenen Stadien des Prostatakarzinoms [Interdisciplinary guideline for the early recognition, diagnosis and therapy of the various stages of prostate carcinoma]. Deutsche Gesellschaft für Urologie e. V. (ed.), p. 53 ff.
- BACKGROUNDFDA (2011): FDA clears new system to perform simultaneous PET, MRI scans. Available on-line at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2011/ucm258700.htm
- BACKGROUNDGauthier 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.
- BACKGROUNDHara T, Kosaka N, Shinoura N, Kondo T. PET imaging of brain tumor with [methyl-11C]choline. J Nucl Med. 1997 Jun;38(6):842-7. PMID 9189127
- BACKGROUNDHara T, Kosaka N, Kishi H. PET imaging of prostate cancer using carbon-11-choline. J Nucl Med. 1998 Jun;39(6):990-5.