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

Insel Gruppe AG, University Hospital Bern

Status and phase: Completed; Phase 3

Conditions: Bladder Cancer; Prostate Cancer

Treatments: Other: Sinerem (USPIO) enhanced MRI; Other: Imaging: diffusion-weighted MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT00622973

SNF320000-113512/1

KEK101_06

SWISSMEDIC2007DR3215

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

A

Other group

Description:

Diffusion-weighted MRI

Treatment:

Other: Imaging: diffusion-weighted MRI

B

Other group

Description:

Sinerem (USPIO)- enhanced MRI

Treatment:

Other: Sinerem (USPIO) enhanced MRI