Clinical trial NCT00622973: USPIO-enhanced and Diffusion-weighted MRI for the Detection of Pelvic Lymph Node Metastases
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Bladder Cancer
Keywords: 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
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2008-02-25
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Discrimination of N positive (N+) vs. N negative (N0) patients (prostate and bladder cancer) using diffusion-weighted imaging, USPIO enhancement and both.
timeFrame: 1 year
measure: Preoperative localization of all suspected positive nodes in accordance to the predefined regions on both sides and in comparison with histopathology.
timeFrame: 1 year
Secondary outcomes:
measure: Node-by-node analysis of USPIO-enhanced and DW-MRI positive lymph nodes with histopathology.
timeFrame: 2-3 years
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: University Hospital Inselspital, Bern, Switzerland
name: Harriet C Thoeny, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Birkhauser 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.
citation: Triantafyllou 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.