Prostate Cancer Clinical Trial
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
Verified date | October 2011 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Patients with histologically proven prostate cancer (T1-2N0M0 Gleason score 6-10) scheduled for radical prostatectomy or patients with histologically proven bladder cancer (T1-3bN0M0G3) scheduled for cystectomy - Written informed consent to participate in this trial. Exclusion Criteria: - Patients with contraindications for MRI (e.g. pacemaker, metal implants, claustrophobia). - Patients in a critical cardiovascular state, with risk of decompensation after administration of the USPIO contrast agent. - Patients with hemochromatosis or an allergy to dextran or iron compounds. - Pregnant or breast-feeding women. - Patients who have received gadolinium complexes within 2 days or iron oxide particles within 7 days before MRI. - Patients who underwent chemotherapy or radiotherapy before surgery. - Patients whose degree of cooperation is incompatible with carrying out the study. - Patients with contraindications to Glucagon administration. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Switzerland | Inselspital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | Swiss National Science Foundation |
Switzerland,
Thoeny HC, Triantafyllou M, Birkhaeuser FD, Froehlich JM, Tshering DW, Binser T, Fleischmann A, Vermathen P, Studer UE. Combined ultrasmall superparamagnetic particles of iron oxide-enhanced and diffusion-weighted magnetic resonance imaging reliably detec — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Discrimination of N positive (N+) vs. N negative (N0) patients (prostate and bladder cancer) using diffusion-weighted imaging, USPIO enhancement and both. | 1 year | No | |
Primary | Preoperative localization of all suspected positive nodes in accordance to the predefined regions on both sides and in comparison with histopathology. | 1 year | No | |
Secondary | Node-by-node analysis of USPIO-enhanced and DW-MRI positive lymph nodes with histopathology. | 2-3 years | No |
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