drugset / Trial / NCT00659334

Imaging of Intravenous (IV) Combidex to Brain, Intra-cerebral Tumors and in Central Nervous System (CNS) Inflammation

NCT00659334 ↗

Non-randomizedParallel-groupOpen-labelDiagnostic

Summary

Combidex (ferumoxtran-10) is an ultra-small iron oxide particle covered with a sugar coating. It has been evaluated as an MRI contrast agent for use in imaging well perfused organs such as the liver and spleen and for imaging lymph nodes. In this study, Combidex is being used to compare the standard imaging agent, Gadolinium, in imaging brain tumors and the area adjacent to the tumor location. Combidex may provide the ability to better see brain tumors and inflammatory lesions on magnetic resonance imaging (MRI) scans. Combidex may be useful in its ability to cross blood vessels into brain tumors, and because of its size and ability to get into the area next to brain tumors, could assist in the treatment of brain tumors with other drugs in the future.

Timeline

Start
2000-08
Primary completion
2010-03
Completion
2010-03

Outcome

Outcome not reported

Stopped: “AMAG not continuing with Combidex, the study drug”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ferumoxtran-10 Diagnostic / imaging agent 2.6 mg/kg Intravenous

Indications