CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 155 enrolled
Drug / intervention
Ferumoxytol +5 moredrug
Likely dose
Ferumoxytol intravenousAI-extracted
Key inclusion· 4
  • Radiological or established histological diagnosis of high-grade glioma, CNS lymphoma, or brain metastases
  • Previously untreated subjects must have a visible lesion on imaging
  • Post-treatment subjects with radiographic abnormalities that may or may not represent recurrent tumor are eligible
  • Pre-imaging radiological scans within 24 hours to 16 weeks prior to study entry
Key exclusion· 10
  • Clinical signs of uncal herniation (acute pupillary enlargement, rapidly developing motor changes, or rapidly decreasing consciousness)
  • Allergy or hypersensitivity to parenteral iron, dextran, iron-dextran, or iron-polysaccharide preparations
  • Pregnancy or lactation
  • Renal insufficiency with GFR <50

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00103038
NCT00103038N/ACompleted

NCI-Sponsored Multi-Disciplinary Study for MR Imaging of Intravenous Superparamagnetic Crystalline Particle Ferumoxytol in Primary High-Grade Brain Tumors and/or Cerebral Metastases

OHSU Knight Cancer Institute·interventional·Posted Feb 8, 2005·Updated Jun 9, 2022

In Brief

A clinical study evaluating 3 Tesla Magnetic Resonance Imaging, Dynamic Contrast-Enhanced Magnetic Resonance Imaging, and 4 other interventions for Central Nervous System Lymphoma and 2 related conditions. Completed, enrolled 155 participants across 1 site.

Detailed Summary

This clinical trial studies magnetic resonance imaging (MRI) using a contrast imaging agent ferumoxytol (ferumoxytol non-stoichiometric magnetite) in improving viewing tumors in patients with high-grade brain tumors or cancer that has spread to the brain. Diagnostic procedures, such as MRI, may help find and diagnose brain tumors and find out how far the disease has spread. The contrast imaging agent ferumoxytol non-stoichiometric magnetite consists of small iron particles taken by the blood stream to the brain and to the area of the tumor. It may help visualize the blood flow going through the tumor better than the standard substance gadolinium-based contrast agent.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2005
Enrollment StartJun 4, 2004
Primary CompletionMay 10, 2016
Study CompletionJun 10, 2016
TodayJul 2, 2026
Enrollment to primary: 11.9 yearsPosted 21.4 years ago

Interventions

3 Tesla Magnetic Resonance Imagingprocedure

Undergo 3T MRI

Dynamic Contrast-Enhanced Magnetic Resonance Imagingprocedure

Undergo 3T DCE-MRI

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imagingprocedure

Undergo 3T DSC-MRI

Ferumoxytoldrug

Given IV

Gadoliniumdrug

Given IV

MRI-Based Angiogramprocedure

Undergo MRA