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

NCT00622973 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2011-10-12

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Imaging: diffusion-weighted MRI

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

OTHER

Sinerem (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.

Sponsors & Collaborators

  • Swiss National Science Foundation

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Harriet C Thoeny, MD · University Hospital Inselspital, Bern, Switzerland

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00622973 on ClinicalTrials.gov