USPIO-Enhanced and Diffusion-Weighted MRI for the Detection of Pelvic Lymph Node Metastases - Tabular View

Tracking Information

First Received Date ^ICMJE

February 13, 2008

Last Updated Date

January 19, 2009

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00622973 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

USPIO-Enhanced and Diffusion-Weighted MRI for the Detection of Pelvic Lymph Node Metastases

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Non-Randomized, Open Label, Factorial Assignment, Efficacy Study

Condition ^ICMJE

Prostate Cancer
Bladder Cancer

Intervention ^ICMJE

Other: Imaging: diffusion-weighted MRI
Other: Sinerem (USPIO) enhanced MRI

Study Arms / Comparison Groups

Other: Diffusion-weighted MRI
Other: Sinerem (USPIO)- enhanced MRI

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2011

Estimated Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Harriet C Thoeny, MD	+41316322111 ext 6199	harriet.Thoeny@insel.ch
Contact: Frederic Birkhaeuser, MD	+41316322111 ext 8801	frederic.birkhaeuser@insel.ch

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00622973

Responsible Party

Harriet C. Thoeny, MD, University Hospital Inselspital, Berne

Study ID Numbers ^ICMJE

SNF320000-113512/1, KEK101_06, SNF320000-113512/1, SWISSMEDIC2007DR3215

Study Sponsor ^ICMJE

University Hospital Inselspital, Berne

Collaborators ^ICMJE

Swiss National Science Foundation

Investigators ^ICMJE

Principal Investigator:

Harriet C Thoeny, MD

University Hospital Inselspital, Bern, Switzerland

Information Provided By

University Hospital Inselspital, Berne

Verification Date

January 2009

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