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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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

Brief 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 Summary:

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.


Sponsor: OHSU Knight Cancer Institute

Current Primary Outcome: Visual and objective quantitative signal intensity [ Time Frame: Up to 2 years ]

For the qualitative analysis, the distribution of the ranks of the image enhancement for each reviewer and the agreement of the two reviewers on the ranks of the image enhancement will be summarized.


Original Primary Outcome: Describe vascular properties of pediatric brain tumors using ferumoxytol for DSC-MRI and GBCA for DCE-MRI in a single MRI session. Describe evolving imaging characteristics of tumor vasculature using DSC-MRI with ferumoxytol and DCE-MRI with GBCA. [ Time Frame: 2 years ]

Current Secondary Outcome:

  • Histology (only in patients for whom a biopsy or surgery is scheduled outside of this protocol) [ Time Frame: Up to 2 years ]
    Appropriate descriptive statistics will be estimated.
  • Number of enhancing lesions [ Time Frame: Up to 2 years ]
    Appropriate descriptive statistics will be estimated.
  • Tumor vascularity [ Time Frame: Up to 2 years ]
    Appropriate descriptive statistics will be estimated.
  • Ultrastructure (only in patients for whom a biopsy or surgery is scheduled outside of this protocol) [ Time Frame: Up to 2 years ]
    Appropriate descriptive statistics will be estimated.
  • Volume of enhancing lesions [ Time Frame: Up to 2 years ]
    Appropriate descriptive statistics will be estimated.


Original Secondary Outcome:

  • Compare and evaluate MRA with ferumoxytol between different time points. [ Time Frame: 2 years ]
  • Describe number and size of tumors imaged [ Time Frame: 2 years ]
  • Assess histology and EM on tissue samples [ Time Frame: 2 years ]
  • Demonstrate differences in patients with prior therapy vs. no prior therapy (radiation and/or chemotherapy). [ Time Frame: 2 years ]


Information By: OHSU Knight Cancer Institute

Dates:
Date Received: September 16, 2009
Date Started: August 2009
Date Completion: December 2017
Last Updated: March 21, 2016
Last Verified: March 2016