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| Descriptive Information Fields | |||||||||
| Brief Title † | USPIO-Enhanced and Diffusion-Weighted MRI for the Detection of Pelvic Lymph Node Metastases | ||||||||
| Official Title † | Noninvasive Detection of Clinically Occult Lymph Node Metastases in Prostate and Bladder Cancer Evaluated by USPIO-Enhanced MRI and Diffusion-Weighted MRI: A Histopathological Correlation | ||||||||
| Brief Summary | Preoperative detection of lymph node metastases in patients with prostate or bladder cancer is crucial for selection of the appropriate treatment strategy (surgery, androgen deprivation with/or without radiation therapy or chemotherapy) and thus for patient prognosis. Until now CT or MRI have been the modalities of choice for preoperative staging procedures. However, current morphological assessment of lymph nodes based on size and shape is unable to detect smaller metastases or liable to give false positive results on lymph nodes with reactive hyperplasia. We hypothesize that USPIO-enhanced MRI combined with DW-MRI will be able to detect pelvic lymph node metastases preoperatively with high sensitivity and specificity. |
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| Detailed Description | |||||||||
| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Diagnostic, Non-Randomized, Open Label, Factorial Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Discrimination of N positive (N+) vs. N negative (N0) patients (prostate and bladder cancer) using diffusion-weighted imaging, USPIO enhancement and both. [ Time Frame: 1 year ] [ Designated as safety issue: No ] Preoperative localization of all suspected positive nodes in accordance to the predefined regions on both sides and in comparison with histopathology. [ Time Frame: 1 year ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Node-by-node analysis of USPIO-enhanced and DW-MRI positive lymph nodes with histopathology. [ Time Frame: 2-3 years ] [ Designated as safety issue: No ] | ||||||||
| Condition † | Prostate Cancer Bladder Cancer |
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| Intervention † | Other: Imaging: diffusion-weighted MRI Other: Sinerem (USPIO) enhanced MRI |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 90 | ||||||||
| Start Date † | September 2007 | ||||||||
| Completion Date | January 2011 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Switzerland | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00622973 | ||||||||
| Organization ID | SNF320000-113512/1 | ||||||||
| Secondary IDs †† | KEK101_06, SNF320000-113512/1, SWISSMEDIC2007DR3215 | ||||||||
| Study Sponsor † | University Hospital Inselspital, Berne | ||||||||
| Collaborators †† | Swiss National Science Foundation | ||||||||
| Investigators † |
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| Information Provided By | University Hospital Inselspital, Berne | ||||||||
| Verification Date | July 2008 | ||||||||
| First Received Date † | February 13, 2008 | ||||||||
| Last Updated Date | July 4, 2008 | ||||||||
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