Adult Brain GlioblastomaNCT00660543
MRI Study With Ferumoxytol in Assessing Early Response in Patients With Glioblastoma Multiforme Receiving Temozolomide and Radiation Therapy
A study testing Gadolinium, Ferumoxytol Non-Stoichiometric Magnetite and Dynamic Contrast-Enhanced Magnetic Resonance Imaging in people with Adult Brain Glioblastoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This pilot clinical trial studies how a magnetic resonance imaging (MRI) study with ferumoxytol works as a contrasting agent in assessing early response in patients with glioblastoma multiforme receiving temozolomide and radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Brain Glioblastoma
- What is being tested?
- Gadolinium, Ferumoxytol Non-Stoichiometric Magnetite and Dynamic Contrast-Enhanced Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have radiologically and histologically confirmed diagnosis of glioblastoma multiforme
- Patients must have measurable disease, defined as evident tumors with gadolinium enhancement on MRI that is measurable in at least one diameter and visible on both axial and sagittal or coronal views
- Life expectancy of greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)
- Patients scheduled for standard therapy (6 weeks radiation therapy (RT) ~ 60 Gy, plus temozolomide 75 mg/m^2 during 6 week [w] RT, and followed routine monthly temozolomide therapy)
- Patients must be on a stable or decreasing dose (up to 8 mg daily) of dexamethasone throughout the study
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- After entry into the study, patients are expected to be followed for at least 1 month after the last infusion of ferumoxytol
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Who cannot join
- Patients who have had chemotherapy or radiotherapy
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ferumoxytol: parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2005); patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion
- Patients with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
- Patients who require monitored anesthesia for MRI scanning
- Patients with history of hemochromatosis or iron overload
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- Patients with renal insufficiency (glomerular filtration rate (GFR) < 50)
- 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
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ferumoxytol
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Early Assessment of Tumor Response to Therapy Using Ferumoxytol (Code 7228) as an MR Contrast Agent in Patients With Glioblastoma Multiforme (MedDRA Code 10018337)
This pilot clinical trial studies how a magnetic resonance imaging (MRI) study with ferumoxytol works as a contrasting agent in assessing early response in patients with glioblastoma multiforme receiving temozolomide and radiation therapy. Ferumoxytol is a very small form of iron particles that are injected into the body and taken up by certain tissues which may make these tissues easier to see during imaging. Diagnostic procedures, such as an MRI study with ferumoxytol, may help measure a patient's response to earlier treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To characterize glioblastoma multiforme (GBM) tumor vascular properties using ferumoxytol (ferumoxytol non-stoichiometric magnetite) and compare to those obtained using gadolinium (Gd) based MRI contrast agent.
II. To characterize vascular changes in GBM tumors associated with standard radio/chemotherapy.
SECONDARY OBJECTIVES:
- Cerebral blood flow (CBF), mean transit time (MTT), and time-to-peak (TTP) perfusion parameters will be measured for each contrast agent and evaluated in post-hoc analysis.
II. To obtain qualitative assessment of tumor vascularity using time-of-flight (TOF) magnetic resonance (MR) angiography techniques.
III. To characterize changes in the apparent diffusion coefficient (ADC) of tumor water associated with standard radio/chemotherapy in GBM.
OUTLINE:
Patients receive gadolinium intravenously (IV) on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo dynamic susceptibility contrast enhanced (DSC) MRI, and dynamic contrast enhanced (DCE) MRI, diffusion-weighted imaging (DWI) (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). Ferumoxytol non-stoichiometric magnetite administration continues in the absence of unacceptable toxicity. Patients also receive temozolomide and undergo radiation therapy per standard of care.
After completion of ferumoxytol non-stoichiometric magnetite administration, patients are followed up for 4-6 weeks and then periodically until the resolution or stabilization of unacceptable toxicities.
- Conditions
- Adult Brain Glioblastoma
- Being tested
- Gadolinium, Ferumoxytol Non-Stoichiometric Magnetite, Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Diffusion Weighted Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GadoliniumDrug
Also called Gd
Given IV
Ferumoxytol Non-Stoichiometric MagnetiteDrug
Also called Fe3O4, Feraheme, Ferumoxytol
Given IV
Dynamic Contrast-Enhanced Magnetic Resonance ImagingOther
Also called DCE MRI, DCE-MRI
Undergo DCE MRI
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance ImagingOther
Also called DSC-MRI, Dynamic Susceptibility Contrast-Enhanced MRI
Undergo DSC MRI
Diffusion Weighted ImagingOther
Also called Diffusion Weighted MRI, DWI, DWI MRI, DWI-MRI
Undergo DWI
MRI-Based AngiogramOther
Also called Magnetic Resonance Angiogram, MRA
Undergo TOF MR angiography
| Study group | Role | What they receive |
|---|---|---|
| Ferumoxytol | Experimental | Patients receive ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). Ferumoxytol non-stoichiometric magnetite administration continues in the absence of unacceptable toxicity. Receives: Drug: Ferumoxytol Non-Stoichiometric Magnetite; Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Other: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging; Other: Diffusion Weighted Imaging; Other: MRI-Based Angiogram |
| Gadoteridol | Active comparator | Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). Receives: Drug: Gadolinium; Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Other: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging; Other: Diffusion Weighted Imaging; Other: MRI-Based Angiogram |
| Gadoteridol Leakage Corrected | Active comparator | Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). Receives: Drug: Gadolinium; Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Other: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging; Other: Diffusion Weighted Imaging; Other: MRI-Based Angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Cerebral Blood Volume (CBV)
Radiographical progression is determined based on RANO criteria.
Measured: At radiographical progression (between 6 and 12 weeks post first dose of chemoradiation)
Tumor Progression on Conventional MR
Tumor progression was assessed by RANO criteria (Wen, 2010).
Measured: Anytime between baseline and 12 weeks post treatment initiation: average 6 weeks post treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startDec 2006
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult Brain GlioblastomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Edward Neuwelt, OHSU Knight Cancer Institute
- Investigators
- Edward Neuwelt, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660543
- Sponsor's protocol ID
- IRB00002753
- Other IDs
- NCI-2015-00224, SOL-06062-LX, 813, NCI-2015-00204, 8097, 2753, P30CA069533
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2008
- Last updated
- 16 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Assessment of Tumor Response to Therapy Using Ferumoxytol (Code 7228) as an MR Contrast Agent in Patients With Glioblastoma Multiforme (MedDRA Code 10018337)
- ClinicalTrials.gov ID
- NCT00660543
- Acronym / sponsor ID
- IRB00002753
- Conditions
- Adult Brain Glioblastoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2006
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Apr 2008 (estimated)
- Results
- Posted 16 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies how a magnetic resonance imaging (MRI) study with ferumoxytol works as a contrasting agent in assessing early response in patients with glioblastoma multiforme receiving temozolomide and radiation therapy. Ferumoxytol is a very small form of iron particles that are injected into the body and taken up by certain tissues which may make these tissues easier to see during imaging. Diagnostic procedures, such as an MRI study with ferumoxytol, may help measure a patient's response to earlier treatment.
Detailed description
PRIMARY OBJECTIVES:
- To characterize glioblastoma multiforme (GBM) tumor vascular properties using ferumoxytol (ferumoxytol non-stoichiometric magnetite) and compare to those obtained using gadolinium (Gd) based MRI contrast agent.
II. To characterize vascular changes in GBM tumors associated with standard radio/chemotherapy.
SECONDARY OBJECTIVES:
- Cerebral blood flow (CBF), mean transit time (MTT), and time-to-peak (TTP) perfusion parameters will be measured for each contrast agent and evaluated in post-hoc analysis.
II. To obtain qualitative assessment of tumor vascularity using time-of-flight (TOF) magnetic resonance (MR) angiography techniques.
III. To characterize changes in the apparent diffusion coefficient (ADC) of tumor water associated with standard radio/chemotherapy in GBM.
OUTLINE:
Patients receive gadolinium intravenously (IV) on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo dynamic susceptibility contrast enhanced (DSC) MRI, and dynamic contrast enhanced (DCE) MRI, diffusion-weighted imaging (DWI) (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). Ferumoxytol non-stoichiometric magnetite administration continues in the absence of unacceptable toxicity. Patients also receive temozolomide and undergo radiation therapy per standard of care.
After completion of ferumoxytol non-stoichiometric magnetite administration, patients are followed up for 4-6 weeks and then periodically until the resolution or stabilization of unacceptable toxicities.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ferumoxytol | Experimental | Drug: Ferumoxytol Non-Stoichiometric Magnetite, Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Other: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Other: Diffusion Weighted Imaging, Other: MRI-Based AngiogramPatients receive ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). Ferumoxytol non-stoichiometric magnetite administration continues in the absence of unacceptable toxicity. |
| Gadoteridol | Active comparator | Drug: Gadolinium, Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Other: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Other: Diffusion Weighted Imaging, Other: MRI-Based AngiogramPatients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). |
| Gadoteridol Leakage Corrected | Active comparator | Drug: Gadolinium, Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Other: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Other: Diffusion Weighted Imaging, Other: MRI-Based AngiogramPatients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have radiologically and histologically confirmed diagnosis of glioblastoma multiforme
- Patients must have measurable disease, defined as evident tumors with gadolinium enhancement on MRI that is measurable in at least one diameter and visible on both axial and sagittal or coronal views
- Life expectancy of greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)
- Patients scheduled for standard therapy (6 weeks radiation therapy (RT) ~ 60 Gy, plus temozolomide 75 mg/m^2 during 6 week [w] RT, and followed routine monthly temozolomide therapy)
Key exclusion criteria (10 listed)
- Patients who have had chemotherapy or radiotherapy
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ferumoxytol: parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2005); patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion
- Patients with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
- Patients who require monitored anesthesia for MRI scanning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GadoliniumAlso: GdGiven IV | Drug | Gadoteridol, Gadoteridol Leakage Corrected |
| Ferumoxytol Non-Stoichiometric MagnetiteAlso: Fe3O4, Feraheme, FerumoxytolGiven IV | Drug | Ferumoxytol |
| Dynamic Contrast-Enhanced Magnetic Resonance ImagingAlso: DCE MRI, DCE-MRIUndergo DCE MRI | Other | Ferumoxytol, Gadoteridol, Gadoteridol Leakage Corrected |
| Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance ImagingAlso: DSC-MRI, Dynamic Susceptibility Contrast-Enhanced MRIUndergo DSC MRI | Other | Ferumoxytol, Gadoteridol, Gadoteridol Leakage Corrected |
| Diffusion Weighted ImagingAlso: Diffusion Weighted MRI, DWI, DWI MRI, DWI-MRIUndergo DWI | Other | Ferumoxytol, Gadoteridol, Gadoteridol Leakage Corrected |
| MRI-Based AngiogramAlso: Magnetic Resonance Angiogram, MRAUndergo TOF MR angiography | Other | Ferumoxytol, Gadoteridol, Gadoteridol Leakage Corrected |
Primary outcome
Mean Cerebral Blood Volume (CBV)
Time frame: At radiographical progression (between 6 and 12 weeks post first dose of chemoradiation)
Radiographical progression is determined based on RANO criteria.
Tumor Progression on Conventional MR
Time frame: Anytime between baseline and 12 weeks post treatment initiation: average 6 weeks post treatment initiation.
Tumor progression was assessed by RANO criteria (Wen, 2010).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Neuwelt principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gadolinium, Ferumoxytol Non-Stoichiometric Magnetite and Dynamic Contrast-Enhanced Magnetic Resonance Imaging in people with Adult Brain Glioblastoma, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Cerebral Blood Volume (CBV) (time frame: At radiographical progression (between 6 and 12 weeks post first dose of chemoradiation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.