Status:
COMPLETED
USPIO-enhanced and Diffusion-weighted MRI for the Detection of Pelvic Lymph Node Metastases
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Swiss National Science Foundation
Conditions:
Prostate Cancer
Bladder Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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 withou...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00622973
Start Date
September 1 2007
End Date
March 1 2011
Last Update
October 12 2011
Active Locations (1)
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1
Inselspital
Bern, Switzerland, 3010