Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103038
Status:
COMPLETED
Last Update Posted:
2022-06-09
First Post:
2005-02-07
Brief Title:
Ferumoxytol in Improving MR Imaging in Patients With High-Grade Brain Tumors or Cerebral Metastases
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
NCI-Sponsored Multi-Disciplinary Study for MR Imaging of Intravenous Superparamagnetic Crystalline Particle Ferumoxytol in Primary High-Grade Brain Tumors andor Cerebral Metastases
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
PRIMARY OBJECTIVES
I Investigate the utility of ferumoxytol and gadolinium-based contrast agent GBCA for improved imaging biomarkers of malignant brain tumors in a single imaging session by comparing dynamic susceptibility contrast DSC determined relative cerebral blood volume rCBV and dynamic contrast enhancement DCE determined vascular permeability derived transfer coefficient Ktrans
SECONDARY OBJECTIVES
I Compare and evaluate magnetic resonance angiography MRA with ferumoxytol between different time points
II Assess number and size of tumors imaged III Assess tumor vascularity IV Assess histology and electron microscopy EM on tissue samples V Assess differences in subjects with prior therapy versus vs no prior therapy radiation andor chemotherapy
VI Assess the long term imaging characteristics of different tumors using DSC and DCE
OUTLINE
Patients receive ferumoxytol non-stoichiometric magnetite intravenously IV beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1 Patients also undergo MRI without contrast at baseline and on day 2 Imaging with ferumoxytol GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years
After completion of study patients are followed up at approximately 4-6 weeks
I Investigate the utility of ferumoxytol and gadolinium-based contrast agent GBCA for improved imaging biomarkers of malignant brain tumors in a single imaging session by comparing dynamic susceptibility contrast DSC determined relative cerebral blood volume rCBV and dynamic contrast enhancement DCE determined vascular permeability derived transfer coefficient Ktrans
SECONDARY OBJECTIVES
I Compare and evaluate magnetic resonance angiography MRA with ferumoxytol between different time points
II Assess number and size of tumors imaged III Assess tumor vascularity IV Assess histology and electron microscopy EM on tissue samples V Assess differences in subjects with prior therapy versus vs no prior therapy radiation andor chemotherapy
VI Assess the long term imaging characteristics of different tumors using DSC and DCE
OUTLINE
Patients receive ferumoxytol non-stoichiometric magnetite intravenously IV beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1 Patients also undergo MRI without contrast at baseline and on day 2 Imaging with ferumoxytol GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years
After completion of study patients are followed up at approximately 4-6 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA137488 | NIH | OHSU Knight Cancer Institute | httpsreporternihgovquickSearchR01CA137488 |
| NCI-2015-00226 | OTHER | None | None |
| ONC-03095-LX | OTHER | None | None |
| IRB00000813 | OTHER | None | None |