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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00622973

Enrollment

130

Registered

2008-02-25

Start date

2007-09-30

Completion date

2011-03-31

Last updated

2011-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Prostate Cancer

Keywords

Prostate cancer, Bladder cancer, Pelvic lymph node metastases, Diffusion-weighted MRI, Sinerem (USPIO)-enhanced MRI, Imaging influence on surgery, Noninvasive detection of pelvic lymph node metastases, Influence of imaging protocol on surgical outcome

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.

Interventions

OTHERImaging: diffusion-weighted MRI

Diffusion-weighted MRI of the entire pelvis to detect lymph node metastases

OTHERSinerem (USPIO) enhanced MRI

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026