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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00622973
• Other study ID #: SNF320000-113512/1
• Secondary ID: KEK101_06SNF3200
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2008
• Last updated: October 7, 2011
• Start date: September 2007
• Est. completion date: March 2011

Study information

• Verified date: October 2011
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bladder Cancer
• Prostate Cancer
• Prostatic Neoplasms
• Urinary Bladder Neoplasms

Intervention

Other:
• Imaging: diffusion-weighted MRI
Diffusion-weighted MRI of the entire pelvis to detect lymph node metastases
• 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.

Locations

Country	Name	City	State
Switzerland	Inselspital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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 detec — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discrimination of N positive (N+) vs. N negative (N0) patients (prostate and bladder cancer) using diffusion-weighted imaging, USPIO enhancement and both.		1 year	No
Primary	Preoperative localization of all suspected positive nodes in accordance to the predefined regions on both sides and in comparison with histopathology.		1 year	No
Secondary	Node-by-node analysis of USPIO-enhanced and DW-MRI positive lymph nodes with histopathology.		2-3 years	No