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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
130
Diffusion-weighted MRI of the entire pelvis to detect lymph node metastases
USPIO (Sinerem) will be administered intravenously immediately after the first MR examination at a dose of 2.6 mg Fe/kg body weight diluted in 100 ml of saline (optimal dose according to: (9, 10)) during a period of about 30 minutes under medical supervision. Postcontrast MR imaging will be performed 24-36 hours after contrast medium injection.
Inselspital
Bern, Switzerland
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
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
Node-by-node analysis of USPIO-enhanced and DW-MRI positive lymph nodes with histopathology.
Time frame: 2-3 years
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