NCT00978562

DSC-MRI With Ferumoxytol and DCE-MRI With Gadolinium in Imaging Vascular Properties in Younger Patients With Brain Tumors

Imaging Vascular Properties of Pediatric Brain Tumors Using DSC-MRI With Ferumoxytol (Code 7228) and DCE-MRI With Gadolinium in a Single Imaging Session: An NCI Sponsored Exploratory Trial

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies dynamic susceptibility-weighted contrast enhanced magnetic resonance imaging (DSC-MRI) after administration of ferumoxytol and dynamic contrast-enhanced MRI (DCE-MRI) after administration of a gadolinium-based contrast agent (GBCA) in viewing the vessels of the brain in younger patients with brain tumors. Ferumoxytol is an experimental form of very small iron particles that are taken by the blood stream to cells adjacent and inside the tumor. These iron particles may make it easier to see the areas of the brain that are affected by tumor. Ferumoxytol may work better than standard GBCA in viewing the vessels of the brain and brain tumor on MRI. Using ferumoxytol and GBCA in the same MRI session may provide more information about tumor blood supply and the extent of the tumor.

Detailed description

PRIMARY OBJECTIVES: I. To describe the vascular properties of pediatric brain tumors using ferumoxytol for DSC-MRI and GBCA for DCE-MRI in pediatric brain tumor (proven or presumptive) patients in a single MRI session. II. To describe evolving imaging characteristics of tumor vasculature using DSC-MRI with ferumoxytol and DCE-MRI with GBCA in pediatric brain tumor patients. SECONDARY OBJECTIVES: I. Compare and evaluate magnetic resonance angiogram (MRA) with ferumoxytol between different time points. II. To describe number and size of tumors imaged. III. To assess histology and electron microscopy (EM) on tissue samples. IV. To demonstrate differences in patients with prior therapy versus (vs.) no prior therapy (radiation and/or chemotherapy). OUTLINE: Patients receive ferumoxytol and gadolinium intravenously (IV) and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years. After completion of study treatment, patients are followed up at approximately 4-6 weeks.

Conditions

• Childhood Brain Neoplasm
• Recurrent Childhood Brain Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Dynamic Contrast-Enhanced Magnetic Resonance Imaging	Undergo DCE-MRI
PROCEDURE	Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging	Undergo DSC-MRI
DRUG	Ferumoxytol Non-Stoichiometric Magnetite	Given IV
DRUG	Gadolinium	Given IV

Timeline

• Start date: 2009-08-01
• Primary completion: 2015-12-01
• Completion: 2018-12-01
• First posted: 2009-09-17
• Last updated: 2022-08-03
• Results posted: 2017-05-23

Locations

1 site across 1 country: United States