NCT00659126

Ferumoxytol- and Gadolinium-Labeled MRI in Measuring Tumors Before or After Treatment in Patients With Primary or Metastatic Brain Tumors

A Phase II Study of Ferumoxytol and Gadolinium Magnetic Resonance Imaging at 3T and 7T in Subjects With Primary or Metastatic Brain Tumors Either Before or After Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well magnetic resonance imaging (MRI) using contrast imaging agent ferumoxytol works in comparison to standard imaging agent gadolinium in measuring tumors in patients undergoing treatment for brain tumors or other tumors that have spread to the brain. Diagnostic procedures, such as MRI, may help find and diagnose disease and find out how far the disease has spread. MRI scans use radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. The contrast imaging agent ferumoxytol consists of small iron particles taken by the blood stream to the brain and to the area of the tumor. It is highly visible on the MRI, and may help visualize the blood flow going through the tumor better than gadolinium can. Using a more sensitive and faster 7 Tesla (7T) magnet MRI in conjunction with a contrast imaging agent may provide a better way to measure tumors than the 3 Tesla (3T) magnet MRI in patients with brain tumors.

Detailed description

PRIMARY OBJECTIVES: I. To compare quantitative blood brain barrier permeability measurements (derived transfer coefficient \[Ktrans\]) of a standard gadolinium (Gd) MRI contrast agent at 3T and 7T using dynamic contrast enhancement (DCE) MRI. II. To compare dynamic susceptibility contrast (DSC) based perfusion measures at 3T and 7T. SECONDARY OBJECTIVES: I. To describe the blood brain barrier permeability to ferumoxytol (ferumoxytol non-stoichiometric magnetite) and to a standard gadolinium-based MRI contrast agent using signal intensity changes as described above. II. To describe cerebral blood volume (CBV) measurements obtained using a standard gadolinium MRI contrast agent and ferumoxytol. III. To evaluate tumor microvascularity on susceptibility-weighted images (SWI). IV. To describe the microscopic distribution of ferumoxytol particles in tissue removed from subjects undergoing surgery. OUTLINE: Patients are assigned to 3T or 7T magnet within the subgroups. Patients receive gadolinium intravenously (IV) on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2. Patients undergo anatomical MRI sequences with 3T or 7T at baseline and on days 1-3. Patients also undergo DSC MRI and DCE MRI on days 1-2. Day 1 and day 2 imaging sessions may be separated by up to 7 days. After completion of study, patients are followed up at approximately 4-6 weeks.

Conditions

• Metastatic Malignant Neoplasm in the Brain
• Primary Brain Neoplasm

Interventions

Type	Name	Description
PROCEDURE	3 Tesla Magnetic Resonance Imaging	Undergo 3T MRI
PROCEDURE	Dynamic Contrast-Enhanced Magnetic Resonance Imaging	Undergo DCE MRI
PROCEDURE	Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging	Undergo DSC MRI
DRUG	Ferumoxytol	Given IV
DRUG	Gadolinium	Given IV
PROCEDURE	High Field Strength Magnetic Resonance Imaging	Undergo 7T MRI
PROCEDURE	Susceptibility Weighted Imaging	Undergo SWI

Timeline

• Start date: 2006-11-16
• Primary completion: 2019-12-31
• Completion: 2020-12-31
• First posted: 2008-04-16
• Last updated: 2023-09-07
• Results posted: 2023-09-07

Locations

1 site across 1 country: United States