MR-Lymphography and Lymph Node Staging in Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00185029|
Recruitment Status : Unknown
Verified September 2005 by Radboud University.
Recruitment status was: Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : September 16, 2005
This proposal is targeted at all patients with prostate cancer who are candidates for either curative surgery or curative radiotherapy in whom lymph node staging is indicated. Recently, it has been shown, that in patients with PSA <10 ng/ml and Gleason score < 7 the risk of lymph node metastases is low. Therefore, unnecessary PLND and non-invasive imaging can be avoided safely in this group. PLND is nowadays performed only in patients with intermediate or high risk for nodal metastases. Thus the subgroup of patients targeted in this study consists of patients with prostate cancer with a PSA >10 ng/ml and Gleason score > 6.
- If the high sensitivity (90%) and negative predictive value (96%) of MRL can be validated in the 8 participating centres, in patients with a negative MRL invasive PLND may be avoided.
- In patients with a positive MRL with enlarged nodes (larger than 8 mm) histological diagnosis may be obtained by imaged guided biopsy, and thus also in these patients avoid PLND. A limitation of image guide biopsy, however, is the 30% false negative rate. [Barentsz, Oyen, Wolf]
- In patients with positive small nodes (smaller than 8 mm) the urologist may, focussed by the MRL findings of a positive node outside his "surgical field-of-view", extend his dissection, and thus improve his accuracy.
- Based on the expected higher sensitivity of MRL this technique will completely replace CT-scanning.
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms Lymphatic Metastasis||Procedure: Ferumoxtran-10 enhanced MRI (MRL)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||396 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MRI With a Lymph Node Specific Contrast Agent: an Alternative for CT-Scanning and Lymph Node Dissection in Patients With Prostate Cancer?|
|Study Start Date :||April 2002|
|Study Completion Date :||August 2005|
- Primary outcome parameters concern accuracy sensitivity, specificity, PPV and NPV of both MRL and CT
- Secondary outcome measures are costs per patient for each strategy. Besides this, quality of life after 6 months of follow up will be part of the analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185029
|Amsterdam, Netherlands, 1066 CX|
|Eindhoven, Netherlands, 5602 ZA|
|Terneuzen, Netherlands, 4535 PA|
|Principal Investigator:||Jelle Barentsz, Phd MD||Radboud University|