Imaging Vascular Properties of Pediatric Brain Tumors Using Ferumoxytol and Gadolinium in a Single Imaging Session
Summary
Current imaging techniques often do not demonstrate the true amount and location of brain tumors, which are both critical factors for treatment decision-making. This purpose of this study is to assess the safety and effectiveness of a new iron containing agent called "ferumoxytol" in improving our ability to image pediatric brain tumors. Ferumoxytol, as well as the usual contrast agent, gadolinium, together will be used to image the blood vessels in pediatric brain tumors. After contrast agent injection into the veins, special magnetic resonance imaging (MRI) scans will be performed to see changes in blood vessels in the brain and tumor.
Description
Patients will be scanned at five different time-points (5 MRI series). Each patient will have a baseline MRI study (gadolinium only, with no ferumoxytol). MRI scans with both ferumoxytol and gadolinium contrast will be performed beginning at least 3 weeks after the baseline scan. The timing of all MRIs will not occur more frequently than every 3 weeks, and all five ferumoxytol/gadolinium scans will take place within 2 years from study entry. There will be a final outpatient clinic visit approximately 1 month after the final ferumoxytol/gadolinium MRI.
Measurements such as size of tumor, blood flow to tumor (perfusion), and leakiness of blood vessels within the tumor (permeability) will be described at each time-point and the information will be evaluated throughout the study. The tumor size will be evaluated by 2 radiologists.
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Conditions
Brain Neoplasms
Intervention
ferumoxytol
Location
Oregon Health & Science University
Portland
Oregon
United States
97239
Status
Recruiting
Source
OHSU Knight Cancer Institute
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00978562
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Brain Neoplasms
Neoplasms of the intracranial components of the central nervous system, including the cerebral hemispheres, basal ganglia, hypothalamus, thalamus, brain stem, and cerebellum. Brain neoplasms are subdivided into primary (originating from brain tissue) and secondary (i.e., metastatic) forms. Primary neoplasms are subdivided into benign and malignant forms. In general, brain tumors may also be classified by age of onset, histologic type, or presenting location in the brain.
Neoplasms By Site
A collective term for precoordinated organ/neoplasm headings locating neoplasms by organ, as BRAIN NEOPLASMS; DUODENAL NEOPLASMS; LIVER NEOPLASMS; etc.
Cerebral Ventricle Neoplasms
Neoplasms located in the brain ventricles, including the two lateral, the third, and the fourth ventricle. Ventricular tumors may be primary (e.g., CHOROID PLEXUS NEOPLASMS and GLIOMA, SUBEPENDYMAL), metastasize from distant organs, or occur as extensions of locally invasive tumors from adjacent brain structures.
Brain Stem Neoplasms
Benign and malignant intra-axial tumors of the MESENCEPHALON; PONS; or MEDULLA OBLONGATA of the BRAIN STEM. Primary and metastatic neoplasms may occur in this location. Clinical features include ATAXIA, cranial neuropathies (see CRANIAL NERVE DISEASES), NAUSEA, hemiparesis (see HEMIPLEGIA), and quadriparesis. Primary brain stem neoplasms are more frequent in children. Histologic subtypes include GLIOMA; HEMANGIOBLASTOMA; GANGLIOGLIOMA; and EPENDYMOMA.
Supratentorial Neoplasms
Primary and metastatic (secondary) tumors of the brain located above the tentorium cerebelli, a fold of dura mater separating the CEREBELLUM and BRAIN STEM from the cerebral hemispheres and DIENCEPHALON (i.e., THALAMUS and HYPOTHALAMUS and related structures). In adults, primary neoplasms tend to arise in the supratentorial compartment, whereas in children they occur more frequently in the infratentorial space. Clinical manifestations vary with the location of the lesion, but SEIZURES; APHASIA; HEMIANOPSIA; hemiparesis; and sensory deficits are relatively common features. Metastatic supratentorial neoplasms are frequently multiple at the time of presentation.
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