Central Nervous System LymphomaNCT00103038
Ferumoxytol in Improving MR Imaging in Patients With High-Grade Brain Tumors or Cerebral Metastases
A study testing 3 Tesla Magnetic Resonance Imaging, Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging in people with Central Nervous System Lymphoma and Malignant Glioma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Lymphoma, Malignant Glioma, Metastatic Malignant Neoplasm in the Brain
- What is being tested?
- 3 Tesla Magnetic Resonance Imaging, Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2004to 10 Jun 2016
- 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
- Subject must have either radiological or established histological diagnosis of the following general categories:
- High-grade glioma/central nervous system (CNS) lymphoma or
- Brain metastases
- Previously untreated subjects must have a lesion on an imaging study
- Post treatment subjects will have radiographic abnormalities that may or may not be recurrent tumor
- Subjects agree to be contacted 4-6 weeks after each study visit
Show all 9Show fewer
- Subjects, or their legal guardian, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
- Sexually active women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study treatment and for the duration of study treatment; should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Pre-imaging radiological scans/studies must be performed approximately 16 weeks prior to study entry; but not less than 24 hours prior
Who cannot join
- Subjects 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
- Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2012); subjects with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion
- Subjects who are pregnant or lactating or who suspect they might be pregnant
- Subjects who require monitored anesthesia for MRI scanning
- Subjects with renal insufficiency; glomerular filtration rate (GFR) < 50
- Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium (Gd) contrast material
Show all 10Show fewer
- Subjects with known hepatic insufficiency or cirrhosis
- Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible
- Subjects with known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions)
- Subjects with three or more drug allergies from separate drug classes
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: NCI-Sponsored Multi-Disciplinary Study for MR Imaging of Intravenous Superparamagnetic Crystalline Particle Ferumoxytol in Primary High-Grade Brain Tumors and/or Cerebral Metastases
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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 and/or 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.
- Conditions
- Central Nervous System Lymphoma, Malignant Glioma, Metastatic Malignant Neoplasm in the Brain
- Being tested
- 3 Tesla Magnetic Resonance Imaging, Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Ferumoxytol, Gadolinium
- Medical subject headings
- Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 Tesla Magnetic Resonance ImagingProcedure or surgery
Also called 3 Tesla MRI, 3T MRI
Undergo 3T MRI
Dynamic Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery
Also called DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Undergo 3T DCE-MRI
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery
Also called Dynamic Susceptibility Contrast-Enhanced MRI
Undergo 3T DSC-MRI
FerumoxytolDrug
Also called Feraheme, FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE
Given IV
GadoliniumDrug
Also called Gd
Given IV
MRI-Based AngiogramProcedure or surgery
Also called Magnetic Resonance Angiogram, MRA
Undergo MRA
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (ferumoxytol, gadolinium, DCE-MRI, DSC-MRI) | Experimental | Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer
Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) 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 will also undergo MRI without contrast at baseline (before 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.
3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI
Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI
Ferumoxytol: Given IV
Gadolinium: Given IV
MRI-Based Angiogram: Undergo MRA Receives: Procedure: 3 Tesla Magnetic Resonance Imaging; Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging; Drug: Ferumoxytol; Drug: Gadolinium; Procedure: MRI-Based Angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility of Femumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Session by Comparing Dynamic Contrast Enhanced Determined Vascular Permeability (Ktrans)
Appropriate descriptive statistics (mean, standard deviation, minimum, median, and maximum) will be estimated for the imaging parameters Ktrans. Frequency distributions of each parameter will also be described to assess normality. Pearson's correlation coefficients will be estimated to describe potential relationships among these various measures.
Measured: Assessed after each visit for up to 6 imaging sessions (up to 5 years)
Utility of Ferumoxytol and Gadolinium Based Contrast Agents 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) Maps.
Compare rCBV measurements in regions of interest obtained from ferumoxytol DSC-MRI with gadolinium based contrast agent (GBCA) MR images to evaluate vascular properties of brain tumors. CBV maps were generated by applying tracer kinetic model to the first pass of the contrast bolus. Voxelwise CBV maps were coregistered to T1 weighted images and then normalized by dividing by the mean of normal appearing white matter CBV in the same region in the contralateral hemisphere. RCBV values (as the area under the signal intensity curve, normalized by the area under the curve for the control region) were obtained. Values range from 0 (low intensity) to 180 (highest intensity).
Measured: Summarized after completion of up to 6 imaging sessions (up to 5 years)
Secondary outcomes (3)
Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Cube Root Volume)
We analyzed 193 sets of post-gadoteriol and 24 hours post-ferumoxytol T1 weighted scans from 58 patient with high grade glioma. Enhancement volumes normalized to normal appearing white matter were calculated with histogram analysis. Enhancement cube root volumes were compared between the two contrast agents. Ferumoxytol and gadolinium enhanced MR images were obtained from each participant.
Measured: Summarized after completion of up to 6 imaging sessions (up to 5 years)
Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Signal Intensity)
We analyzed 193 sets of post-gadoteriol and 24 hours post-ferumoxytol T1 weighted scans from 58 patient with high grade glioma. Signal intensities normalized to normal appearing white matter were calculated with histogram analysis. Signal intensities were compared between the two contrast agents. Ferumoxytol and gadolinium enhanced MR images were obtained from each participant. Signal intensities were normalized to the signal intensity value of non-enhancing voxels inside the manual ROI (the relative complement of the final mask in Q, i.e. Q \ [A ∩ B ∩ C]). Higher values in signal intensity indicated increased image enhancement.
Measured: Summarized after completion of up to 6 imaging sessions (up to 5 years)
Overall Survival in Participants With Pseudoprogression With or Real Tumor Progression Using Ferumoxytol Enchanced Perfusion MRI
We evaluated overall survival in patients with pseudopregression or real tumor progression by using relative cerebral blood volume values on ferumoxytol enhanced perfusion MRIs.
Measured: Assessed after each visit for up to 6 imaging sessions (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2005 (estimated)
- Study start4 Jun 2004
- Primary completion10 May 2016
- Study completion10 Jun 2016
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 Central Nervous System LymphomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 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
- NCT00103038
- Sponsor's protocol ID
- IRB00000813
- Other IDs
- NCI-2015-00226, ONC-03095-LX, IRB00000813, R01CA137488
- Status last verified
- May 2022
- First submitted
- 7 Feb 2005
- Last updated
- 9 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NCI-Sponsored Multi-Disciplinary Study for MR Imaging of Intravenous Superparamagnetic Crystalline Particle Ferumoxytol in Primary High-Grade Brain Tumors and/or Cerebral Metastases
- ClinicalTrials.gov ID
- NCT00103038
- Acronym / sponsor ID
- IRB00000813
- Conditions
- Central Nervous System Lymphoma, Malignant Glioma, Metastatic Malignant Neoplasm in the Brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Jun 2004 (actual)
- Primary completion
- 10 May 2016 (actual)
- Study completion
- 10 Jun 2016 (actual)
- First posted
- 8 Feb 2005 (estimated)
- Results
- Posted 9 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 and/or 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (ferumoxytol, gadolinium, DCE-MRI, DSC-MRI) | Experimental | Procedure: 3 Tesla Magnetic Resonance Imaging, Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Drug: Ferumoxytol, Drug: Gadolinium, Procedure: MRI-Based AngiogramStudy patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) 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 will also undergo MRI without contrast at baseline (before 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. 3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI Ferumoxytol: Given IV Gadolinium: Given IV MRI-Based Angiogram: Undergo MRA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject must have either radiological or established histological diagnosis of the following general categories:
- Previously untreated subjects must have a lesion on an imaging study
- Post treatment subjects will have radiographic abnormalities that may or may not be recurrent tumor
- Subjects agree to be contacted 4-6 weeks after each study visit
- Subjects, or their legal guardian, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Key exclusion criteria (10 listed)
- Subjects 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
- Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2012); subjects with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion
- Subjects who are pregnant or lactating or who suspect they might be pregnant
- Subjects who require monitored anesthesia for MRI scanning
- Subjects with renal insufficiency; glomerular filtration rate (GFR) < 50
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 |
|---|---|---|
| 3 Tesla Magnetic Resonance ImagingAlso: 3 Tesla MRI, 3T MRIUndergo 3T MRI | Procedure or surgery | Diagnostic (ferumoxytol, gadolinium, DCE-MRI, DSC-MRI) |
| Dynamic Contrast-Enhanced Magnetic Resonance ImagingAlso: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRIUndergo 3T DCE-MRI | Procedure or surgery | Diagnostic (ferumoxytol, gadolinium, DCE-MRI, DSC-MRI) |
| Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance ImagingAlso: Dynamic Susceptibility Contrast-Enhanced MRIUndergo 3T DSC-MRI | Procedure or surgery | Diagnostic (ferumoxytol, gadolinium, DCE-MRI, DSC-MRI) |
| FerumoxytolAlso: Feraheme, FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITEGiven IV | Drug | Diagnostic (ferumoxytol, gadolinium, DCE-MRI, DSC-MRI) |
| GadoliniumAlso: GdGiven IV | Drug | Diagnostic (ferumoxytol, gadolinium, DCE-MRI, DSC-MRI) |
| MRI-Based AngiogramAlso: Magnetic Resonance Angiogram, MRAUndergo MRA | Procedure or surgery | Diagnostic (ferumoxytol, gadolinium, DCE-MRI, DSC-MRI) |
Primary outcome
Utility of Femumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Session by Comparing Dynamic Contrast Enhanced Determined Vascular Permeability (Ktrans)
Time frame: Assessed after each visit for up to 6 imaging sessions (up to 5 years)
Appropriate descriptive statistics (mean, standard deviation, minimum, median, and maximum) will be estimated for the imaging parameters Ktrans. Frequency distributions of each parameter will also be described to assess normality. Pearson's correlation coefficients will be estimated to describe potential relationships among these various measures.
Utility of Ferumoxytol and Gadolinium Based Contrast Agents 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) Maps.
Time frame: Summarized after completion of up to 6 imaging sessions (up to 5 years)
Compare rCBV measurements in regions of interest obtained from ferumoxytol DSC-MRI with gadolinium based contrast agent (GBCA) MR images to evaluate vascular properties of brain tumors. CBV maps were generated by applying tracer kinetic model to the first pass of the contrast bolus. Voxelwise CBV maps were coregistered to T1 weighted images and then normalized by dividing by the mean of normal appearing white matter CBV in the same region in the contralateral hemisphere. RCBV values (as the area under the signal intensity curve, normalized by the area under the curve for the control region) were obtained. Values range from 0 (low intensity) to 180 (highest intensity).
3 secondary outcomes
Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Cube Root Volume)
Time frame: Summarized after completion of up to 6 imaging sessions (up to 5 years)
Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Signal Intensity)
Time frame: Summarized after completion of up to 6 imaging sessions (up to 5 years)
Overall Survival in Participants With Pseudoprogression With or Real Tumor Progression Using Ferumoxytol Enchanced Perfusion MRI
Time frame: Assessed after each visit for up to 6 imaging sessions (up to 5 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- 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 3 Tesla Magnetic Resonance Imaging, Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging in people with Central Nervous System Lymphoma and Malignant Glioma, 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 9 Jun 2022. 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 9 Jun 2022). 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?
Utility of Femumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Session by Comparing Dynamic Contrast Enhanced Determined Vascular Permeability (Ktrans) (time frame: Assessed after each visit for up to 6 imaging sessions (up to 5 years)). 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 9 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.