USPIO-enhanced and Diffusion-weighted MRI for the Detection of Pelvic Lymph Node Metastases

Phase 3

Completed

• Conditions: Prostate Cancer; Bladder Cancer
• Interventions: Other: Sinerem (USPIO) enhanced MRI

• Registration Number: NCT00622973
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-22
• Study First Posted: 2008-02-25
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-07
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
B	Sinerem (USPIO) enhanced MRI	Sinerem (USPIO)- enhanced MRI

Primary Outcome Measures

Name	Time	Method
Discrimination of N positive (N+) vs. N negative (N0) patients (prostate and bladder cancer) using diffusion-weighted imaging, USPIO enhancement and both.	1 year
Preoperative localization of all suspected positive nodes in accordance to the predefined regions on both sides and in comparison with histopathology.	1 year

Secondary Outcome Measures

Name	Time	Method
Node-by-node analysis of USPIO-enhanced and DW-MRI positive lymph nodes with histopathology.	2-3 years

Trial Locations

Locations (1)

Inselspital; 🇨🇭 Bern, Switzerland