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USPIO-Enhanced and Diffusion-Weighted MRI for the Detection of Pelvic Lymph Node Metastases
This study is currently recruiting participants.
Study NCT00622973   Information provided by University Hospital Inselspital, Berne
First Received: February 13, 2008   Last Updated: January 19, 2009   History of Changes

February 13, 2008
January 19, 2009
September 2007
September 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00622973 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
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

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.

 
Phase III
Interventional
Diagnostic, Non-Randomized, Open Label, Factorial Assignment, Efficacy Study
  • Prostate Cancer
  • Bladder Cancer
  • Other: Imaging: diffusion-weighted MRI
  • Other: Sinerem (USPIO) enhanced MRI
  • Other: Diffusion-weighted MRI
  • Other: Sinerem (USPIO)- enhanced MRI
Thoeny HC, Triantafyllou M, Birkhaeuser FD, Froehlich JM, Tshering DW, Binser T, Fleischmann A, Vermathen P, Studer UE. Combined Ultrasmall Superparamagnetic Particles of Iron Oxide-Enhanced and Diffusion-Weighted Magnetic Resonance Imaging Reliably Detect Pelvic Lymph Node Metastases in Normal-Sized Nodes of Bladder and Prostate Cancer Patients. Eur Urol. 2009 Jan 7; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
90
January 2011
September 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact: Harriet C Thoeny, MD +41316322111 ext 6199 harriet.Thoeny@insel.ch
Contact: Frederic Birkhaeuser, MD +41316322111 ext 8801 frederic.birkhaeuser@insel.ch
Switzerland
 
NCT00622973
Harriet C. Thoeny, MD, University Hospital Inselspital, Berne
SNF320000-113512/1, KEK101_06, SNF320000-113512/1, SWISSMEDIC2007DR3215
University Hospital Inselspital, Berne
Swiss National Science Foundation
Principal Investigator: Harriet C Thoeny, MD University Hospital Inselspital, Bern, Switzerland
University Hospital Inselspital, Berne
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP