Assessing Dynamic Magnetic Resonance (MR) Imaging in Patients With Recurrent High Grade Glioma Receiving Chemotherapy

Pilot Study to Compare Dynamic MR Imaging Changes in Patients With Recurrent High Grade Glioma, Receiving an Antiangiogenic Drug, Bevacizumab, Versus Dexamethasone. Dual Agent MR Imaging Study, Using Gadolinium and Ferumoxytol (Code 7228)

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00769093

Enrollment

Registered

2008-10-08

Start date

2008-10-31

Completion date

2014-07-31

Last updated

2017-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Neoplasms

Keywords

ferumoxytol, diagnostic imaging

Brief summary

The purpose of this study is to learn more about imaging changes induced by a new therapeutic agent, bevacizumab with the standard steroid, dexamethasone in patients with high grade glioma. Magnetic resonance imaging (MRI) will be used to evaluate the difference between the 2 treatments. The usual contrast agent (gadolinium) and an iron containing contrast agent called ferumoxytol may help us to evaluate the differences between bevacizumab and dexamethasone effects on imaging of a brain tumor called high grade glioma. For this purpose, after intravenous contrast agent injection, special MR scans (called: dynamic perfusion, blood-brain barrier (BBB) permeability measurement) will be performed to see the microvascular changes in the brain and tumor.

Detailed description

Adult patients (\>18 years old) with recurrent high grade glioma (confirmed by radiology and tissue sample), who have progressed on prior temozolomide + radiation therapy, will be recruited from the neurology, neurosurgery, or neuro-oncology clinics. Patients will be enrolled if they meet the study inclusion and exclusion criteria Patients will be scanned at four different time-points (4 MRI series) (1) before the beginning of the treatment (base line), (2) Three weeks after the first treatment, (3) Three weeks after the second treatment, and (4) at time of progression of the disease. Each MRI time-point will consist of a series of MRI's on three consecutive days. On the first day, gadolinium (0.1 mmol/kg) will be injected for the MRI scan. On the following day ferumoxytol (2 mg/kg) and on the third day, the MRI scan will be done without additional contrast agent, to see the delayed contrast enhancement of ferumoxytol. Subjects will be on treatment including a chemotherapeutic agent called carboplatin combined with either bevacizumab or dexamethasone; 6 patients will receive carboplatin-bevacizumab, followed by carboplatin-dexamethasone, another 6 patients will receive carboplatin- dexamethasone, followed by carboplatin-bevacizumab. After the 3rd time-point, all the patients will continue on carboplatin-bevacizumab treatment (which is currently not an FDA approved combination for brain tumors, however it is widely used throughout the country).There will be monthly clinical visits with clinical MRI until progression of the disease. There will be a follow up visit, 1 month after the last ferumoxytol injection.

Interventions

DRUGFerumoxytol

2 mg/kg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Signed Informed Consent Form * Age equal or greater than 18 years * Histologically confirmed high grade glioma * Radiographic demonstration of disease progression following prior therapy of temozolomide + radiation * Patient scheduled for bevacizumab + standard IV chemotherapy therapy * Bi-dimensionally measurable disease on gadolinium enhanced T1 weighted MR scans * An interval of at least 4 weeks since prior surgical resection * Patients corticosteroid dose must be 4 mg per day or less. * Karnofsky performance status greater than or equal to 50 * Life expectancy greater than 12 weeks * Ability to comply with study and follow-up procedures

Exclusion criteria

* Pregnant or nursing females * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Known liver function insufficiency, stage IV or V renal insufficiency * Disease and Treatment History: Prior treatment with bevacizumab, or another vascular endothelial growth factor (VEGF) or VEGFR-targeted agent; Need for urgent palliative intervention for primary disease (e.g., impending herniation * Bevacizumab

Design outcomes

Primary

Measure	Time frame
The primary objective of this project is to describe quantitative imaging changes of brain tumor vascularity after anti-angiogenic therapy versus steroid therapy. This objective will be accomplished with the following aims and associated hypotheses.	15 weeks
To describe changes of quantitative blood brain barrier permeability measurements (Ktrans) of a standard gadolinium (Gd) MRI contrast between bevacizumab anti-angiogenic therapy and dexamethasone.	15 weeks
To describe relative cerebral blood volume (rCBV) changes obtained using ferumoxytol an iron oxide nanoparticle blood pool agent.	15 weeks

Secondary

Measure	Time frame
To assess vascular dynamic parameters (rCBV and Ktrans) values at progression.	at progression
To describe the changes of the vascular dynamic parameters (rCBV, Ktrans) with the changes of standard gadolinium enhancing tumor volume	15 weeks
To describe post contrast tumor volume (enhancement) of gadolinium and ferumoxytol.	15 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026