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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | August 23, 2007 | ||||||||||||
| Last Updated Date | November 17, 2008 | ||||||||||||
| Start Date ICMJE | December 2007 | ||||||||||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
Detection of local and distant prostate cancer foci proven by histopathological results [ Time Frame: within <2 weeks after PET/MRI ] | ||||||||||||
| Change History | Complete list of historical versions of study NCT00520546 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Clinical Value of 18F-Ethylcholine-Positron Emission Tomography (PET) Combined With Endorectal MRI for Pre-Therapeutic Staging of Prostate Cancer | ||||||||||||
| Official Title ICMJE | Clinical Value of 18F-Ethylcholine-Positron-Emission-Tomography Combined With Magnetic Resonance Imaging by Software Fusion for Pre-Therapeutic Staging of Prostate Cancer | ||||||||||||
| Brief Summary | 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. |
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| 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). |
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| Study Phase | Phase III | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Diagnostic, Open Label, Single Group Assignment, Efficacy Study | ||||||||||||
| Condition ICMJE | Prostate Cancer | ||||||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | Other: Patients with histologically diagnosed prostate cancer (by needle biopsy) before surgery (radical prostatectomy). | ||||||||||||
| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 43 | ||||||||||||
| Estimated Completion Date | December 2009 | ||||||||||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||||||
| Ages | 50 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00520546 | ||||||||||||
| Responsible Party | Dr. Markus Hartenbach, Institute of Radiobiology of the GFAF | ||||||||||||
| Study ID Numbers ICMJE | 12K3-S-140708, EudraCT-Number: 2006-003933-33 | ||||||||||||
| Study Sponsor ICMJE | German Federal Armed Forces | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | German Federal Armed Forces | ||||||||||||
| Verification Date | November 2008 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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