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NCT00659334 · ClinicalTrials.gov registry record · Phase 2
Imaging of Intravenous (IV) Combidex to Brain, Intra-cerebral Tumors and in Central Nervous System (CNS) Inflammation
A Phase 2 study, sponsored by OHSU Knight Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
NCT00659334: Clinical Trial Phase 2 study, sponsored by OHSU Knight Cancer Institute.
NCT00659334 is a Phase 2 study that was terminated before completion, run by OHSU Knight Cancer Institute. The registered enrollment target is 116 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00659334, a Phase 2 study, was terminated before completion, sponsored by OHSU Knight Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
Study 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.
Primary Outcome
Signal intensity change in participants with Pre and 24 hours Post Combidex on T1, T2, T2\* MRI sequences will be assessed (some patients undergo scans at 3 and 72 hours in order to assess radiographic changes at these time points). Combidex will be administered in dose 2.6 mg/kg in adults with high and low grade gliomas, metastases, meningiomas, and PNET; and in pediatric patients with astrocytomas grade i-iv, brain stem gliomas, ependymomas, CNS germ cell tumors, and PNET.
Interventions
- PROCEDURE Neurosurgery
- DRUG Ferumoxtran-10 (Combidex)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2000-08 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
Why NCT00659334 stopped before completion
NCT00659334 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Neurosurgery is the first listed.
NCT00659334 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00659334 about?
NCT00659334 is a clinical study titled "Imaging of Intravenous (IV) Combidex to Brain, Intra-cerebral Tumors and in Central Nervous System (CNS) Inflammation". 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...
What is the current status of trial NCT00659334?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2000-08. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00659334?
The interventions under investigation include: Neurosurgery (PROCEDURE), Ferumoxtran-10 (Combidex) (DRUG).
Who is sponsoring clinical trial NCT00659334?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00659334's enrollment target sits among peer trials
116 623rd of 2000 higher than 1,375 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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