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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00622973
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : October 12, 2011
Swiss National Science Foundation
Information provided by:
University Hospital Inselspital, Berne

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : September 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Diffusion-weighted MRI
Other: Imaging: diffusion-weighted MRI
Diffusion-weighted MRI of the entire pelvis to detect lymph node metastases

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

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Node-by-node analysis of USPIO-enhanced and DW-MRI positive lymph nodes with histopathology. [ Time Frame: 2-3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00622973

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Harriet C. Thoeny, MD, University Hospital Inselspital, Berne Identifier: NCT00622973    
Other Study ID Numbers: SNF320000-113512/1
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011
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:
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Prostatic Neoplasms
Neoplasm Metastasis
Urinary Bladder Neoplasms
Body Weight
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms