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| Sponsor: | German Federal Armed Forces |
|---|---|
| Information provided by: | German Federal Armed Forces |
| ClinicalTrials.gov Identifier: | NCT00520546 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Other: 18F-Ethylcholine Positron Emission Tomography Other: Endorectal Magnetic Resonance Imaging (1.5T) |
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 18F-Ethylcholine-Positron-Emission-Tomography Combined With Magnetic Resonance Imaging by Software Fusion for Pre-Therapeutic Staging of Prostate Cancer |
| Estimated Enrollment: | 43 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Patients with histologically diagnosed prostate cancer (by needle biopsy) before surgery (radical prostatectomy).
|
Other: 18F-Ethylcholine Positron Emission Tomography
One dosage of 3,3 MBq fluorine-18 ethylcholine intravenous. Measure time: about 60-80 minutes.
Other: Endorectal Magnetic Resonance Imaging (1.5T)
Non-contrast-enhanced MRI with applied endorectal and body-array coil. Measure time: approximately 45 minutes.
|
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).
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Markus Hartenbach, Doctor | +498931683925 | markushartenbach@bundeswehr.org |
| Contact: Burkhard Klemenz, Doctor | +498973117101850 | burkhardklemenz@bundeswehr.org |
| Germany | |
| German Federal Armed Forces Hospital | Recruiting |
| Ulm, Baden-Württemberg, Germany, D 89081 | |
| Contact: Burkhard Klemenz, Dr. +4973117101850 burkhardklemenz@bundeswehr.org | |
| Sub-Investigator: Burkhard Klemenz, Dr. | |
| Principal Investigator: Christoph Sparwasser, Prof. Dr. | |
| Sub-Investigator: Burkhardt Danz, Dr. | |
| Study Director: | Markus Hartenbach, Dr. | Institute of Radiobiology, German Federal Armed Forces, Munich |
| Principal Investigator: | Christoph Sparwasser, Prof. Dr. | German Federal Armed Forces Hospital Ulm, Dep. of Urology |
| Study Chair: | Burkhard Klemenz, Dr. | German Federal Armed Forces Hospital Ulm, Dep. of Nuclear Medicine |
More Information
| Responsible Party: | Dr. Markus Hartenbach, Institute of Radiobiology of the GFAF |
| ClinicalTrials.gov Identifier: | NCT00520546 History of Changes |
| Other Study ID Numbers: | 12K3-S-140708, EudraCT-Number: 2006-003933-33 |
| Study First Received: | August 23, 2007 |
| Last Updated: | November 17, 2008 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
PET MRI Choline FEC prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
