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
3 other identifiers
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 prostate-cancer
Started Sep 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 13, 2008
CompletedFirst Posted
Study publicly available on registry
February 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedOctober 12, 2011
October 1, 2011
3.5 years
February 13, 2008
October 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Discrimination of N positive (N+) vs. N negative (N0) patients (prostate and bladder cancer) using diffusion-weighted imaging, USPIO enhancement and both.
1 year
Preoperative localization of all suspected positive nodes in accordance to the predefined regions on both sides and in comparison with histopathology.
1 year
Secondary Outcomes (1)
Node-by-node analysis of USPIO-enhanced and DW-MRI positive lymph nodes with histopathology.
2-3 years
Study Arms (2)
A
OTHERDiffusion-weighted MRI
B
OTHERSinerem (USPIO)- enhanced MRI
Interventions
Diffusion-weighted MRI of the entire pelvis to detect lymph node metastases
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inselspital
Bern, 3010, Switzerland
Related Publications (3)
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 Apr;55(4):761-9. doi: 10.1016/j.eururo.2008.12.034. Epub 2009 Jan 7.
PMID: 19144456RESULTBirkhauser FD, Studer UE, Froehlich JM, Triantafyllou M, Bains LJ, Petralia G, Vermathen P, Fleischmann A, Thoeny HC. Combined ultrasmall superparamagnetic particles of iron oxide-enhanced and diffusion-weighted magnetic resonance imaging facilitates detection of metastases in normal-sized pelvic lymph nodes of patients with bladder and prostate cancer. Eur Urol. 2013 Dec;64(6):953-60. doi: 10.1016/j.eururo.2013.07.032. Epub 2013 Jul 30.
PMID: 23916692DERIVEDTriantafyllou M, Studer UE, Birkhauser FD, Fleischmann A, Bains LJ, Petralia G, Christe A, Froehlich JM, Thoeny HC. Ultrasmall superparamagnetic particles of iron oxide allow for the detection of metastases in normal sized pelvic lymph nodes of patients with bladder and/or prostate cancer. Eur J Cancer. 2013 Feb;49(3):616-24. doi: 10.1016/j.ejca.2012.09.034. Epub 2012 Oct 18.
PMID: 23084842DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harriet C Thoeny, MD
University Hospital Inselspital, Bern, Switzerland
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 13, 2008
First Posted
February 25, 2008
Study Start
September 1, 2007
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
October 12, 2011
Record last verified: 2011-10