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

This study has been completed.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00622973
First received: February 13, 2008
Last updated: October 7, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Bladder Cancer
 Other: Imaging: diffusion-weighted MRI
Other: Sinerem (USPIO) enhanced MRI
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Discrimination of N positive (N+) vs. N negative (N0) patients (prostate and bladder cancer) using diffusion-weighted imaging, USPIO enhancement and both. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Preoperative localization of all suspected positive nodes in accordance to the predefined regions on both sides and in comparison with histopathology. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Node-by-node analysis of USPIO-enhanced and DW-MRI positive lymph nodes with histopathology. [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: September 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
Diffusion-weighted MRI
 Other: Imaging: diffusion-weighted MRI
Diffusion-weighted MRI of the entire pelvis to detect lymph node metastases
B
Sinerem (USPIO)- enhanced MRI
 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.
Other Name: SINEREM

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622973

Locations
Switzerland
Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Swiss National Science Foundation
Investigators
Principal Investigator: Harriet C Thoeny, MD University Hospital Inselspital, Bern, Switzerland
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Harriet C. Thoeny, MD, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00622973     History of Changes
Other Study ID Numbers: SNF320000-113512/1, KEK101_06, SNF320000-113512/1, SWISSMEDIC2007DR3215
Study First Received: February 13, 2008
Last Updated: October 7, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:
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

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Body Weight
Neoplasm Metastasis
Prostatic Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013