Clinical trial NCT00659334: Imaging of Intravenous (IV) Combidex to Brain, Intra-cerebral Tumors and in Central Nervous System (CNS) Inflammation
Official title: Multi-disciplinary Study: MR, Histologic and EM Imaging of Intravenous Superparamagnetic Crystalline Particles (Combidex) to Brain, Intra-cerebral Tumors and in CNS Inflammation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Brain Neoplasms
Keywords: Combidex
Diagnostic imaging
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-04-16
Enrollment: 116
Sex: ALL
Minimum age (years): 5
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Combidex (ferumoxtran-10) is an ultra-small iron oxide particle covered with a sugar coating. It has been evaluated as an MRI contrast agent for use in imaging well perfused organs such as the liver and spleen and for imaging lymph nodes. In this study, Combidex is being used to compare the standard imaging agent, Gadolinium, in imaging brain tumors and the area adjacent to the tumor location. Combidex may provide the ability to better see brain tumors and inflammatory lesions on magnetic resonance imaging (MRI) scans. Combidex may be useful in its ability to cross blood vessels into brain tumors, and because of its size and ability to get into the area next to brain tumors, could assist in the treatment of brain tumors with other drugs in the future.

Detailed description: Subjects are recruited as patients in one of the neurology, neurosurgery or neuro-oncology clinics at OHSU. There are four groups of the study:

* Subjects receive the combidex infusion only.
* Subjects receive Combidex and undergo a previously schedule neurosurgery.
* Subjects undergo surgery only and provide a sample of their tumor tissue to be used in pathology studies of Combidex.
* Subjects with MS or stroke are invited to participate in receiving Combidex to evaluate the effectiveness of enhancing the area of damage within the brain.

Subjects are deemed eligible for the study and undergo a baseline MRI within 28 days of receiving Combidex. Subjects receiving Combidex are admitted for a half day into the Oregon Clinical \& Translational Research Institute(OCTRI). Combidex is infused I.V. over 30 minutes. Subjects are monitored for side effects and are discharged within about 5 hours after the infusion, if no complications have been noted. Subjects return 24 hours after the infusion for a post infusion MRI scan and return again to one of the neurology clinics for one month follow-up. Subjects enrolled in group 2 undergo surgery 1-2 days after the Combidex infusion and also undergo a 24 post infusion MRI and return for one month follow-up. These subjects are also followed closely by the neurosurgical physician during the course of follow-up. Subjects enrolled in group 3 only undergo surgery and agree to have a piece of their tumor resection or biopsy donated for use in the study. Group 4 is the same as group 1, except the patient population includes multiple sclerosis and stroke instead of patients with brain tumors.

Eligibility criteria: Inclusion Criteria:

* Brain tumor or CNS inflammatory lesion including stroke or MS
* 5 yrs old or older
* Able to undergo MRI without general anesthesia
* Agree to be followed for 1 month following infusion of Combidex
* Sign a written informed consent
* If female and of child-bearing potential, be postmenopausal, sterile, or be on birth control for 1 month prior to study
* Must have a pre-treatment MRI within 28 days before study

Exclusion Criteria:

* Clinically significant signs of uncal herniation
* Allergy to study drug, Combidex
* Hepatic insufficiency
* Stage IV or V renal insufficiency
* If female, pregnant or lactating
* Require anesthesia for MRI scanning
* Hemachromatosis

Primary outcomes:
measure: Number of Participants Who Experience Optimal Imaging in Adult and Pediatric Brain Tumors to Establish Timing and Sequencing Parameters of Combidex.
timeFrame: 24 hours (some patients between 3 and 72 hours) after administration of Combidex
Secondary outcomes:
measure: Assess the Cellular Uptake of Particles in Brain Tumor Patients by Comparing Imaging Results With Histology and Electron Microscopic Examination of Biopsy Tissue
timeFrame: 2 years
measure: Compare Combidex Imaging in Brain Tumor Patients, With Other CNS Inflammatory Lesions Such as Multiple Sclerosis and Stroke.
timeFrame: 2 years
measure: Compare Pre- and Post-op Gd Enhanced MRI Combidex Enhanced MR Imaging Done Pre-, Intra- and Post-operatively, to Assess the Degree of Resection and Residual Tumor.
timeFrame: 2 years
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Edward A Neuwelt, MD
role: PRINCIPAL_INVESTIGATOR
References: