Childhood Brain NeoplasmEarly Phase 1NCT00978562

DSC-MRI With Ferumoxytol and DCE-MRI With Gadolinium in Imaging Vascular Properties in Younger Patients With Brain Tumors

A Early Phase 1 study testing Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging and Ferumoxytol Non-Stoichiometric Magnetite in people with Childhood Brain Neoplasm and Recurrent Childhood Brain Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 to 18 years
Conditions the study is for: Childhood Brain Neoplasm, Recurrent Childhood Brain Neoplasm
What is being tested?: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging and Ferumoxytol Non-Stoichiometric Magnetite
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Aug 2009to Dec 2018
Phase: Early Phase 1
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 5 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Participant must have either radiological (presumptive) or established (proven) histological diagnosis of a brain tumor or lesion
Previously untreated participants must have a measureable lesion on an imaging study
Participants undergoing active treatment, or who have completed treatment, will have radiographic abnormalities that may or may not be recurrent tumor
Those participants requiring surgical intervention for diagnostic and/or therapeutic purposes as necessary for their disease are eligible; the tissue may be assessed by histology and/or EM for iron particles; only clinically indicated biopsy and/or surgery will be done
Participants may have had prior therapy for the primary brain tumor, including surgery, radiotherapy or chemotherapy
After entry into the study, participants agree to be followed for up to 6 weeks after the final infusion of ferumoxytol

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All participants, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Baseline MRI studies for participants receiving ferumoxytol must be performed within 16 weeks of study entry
Sexually active women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; 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

Who cannot join

Participants 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
Participants with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations, are not eligible; participants with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion
Participants who are pregnant, lactating, or who suspect they might be pregnant are not eligible
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than 2.5 x upper limits of normal
Glomerular filtration rate (GFR) < 50
Participants 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 GBCA

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Participants with known hepatic insufficiency or cirrhosis
Human immunodeficiency virus (HIV)-positive participants on combination antiretroviral therapy are ineligible
Participants that have a known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions)

Trial locations and contacts

1 site in 1 country.

United States1 site

OHSU Knight Cancer Institute
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Imaging Vascular Properties of Pediatric Brain Tumors Using DSC-MRI With Ferumoxytol (Code 7228) and DCE-MRI With Gadolinium in a Single Imaging Session: An NCI Sponsored Exploratory Trial

This clinical trial studies dynamic susceptibility-weighted contrast enhanced magnetic resonance imaging (DSC-MRI) after administration of ferumoxytol and dynamic contrast-enhanced MRI (DCE-MRI) after administration of a gadolinium-based contrast agent (GBCA) in viewing the vessels of the brain in younger patients with brain tumors. Ferumoxytol is an experimental form of very small iron particles that are taken by the blood stream to cells adjacent and inside the tumor. These iron particles may make it easier to see the areas of the brain that are affected by tumor. Ferumoxytol may work better than standard GBCA in viewing the vessels of the brain and brain tumor on MRI. Using ferumoxytol and GBCA in the same MRI session may provide more information about tumor blood supply and the extent of the tumor.

Read the detailed description

PRIMARY OBJECTIVES:

To describe the vascular properties of pediatric brain tumors using ferumoxytol for DSC-MRI and GBCA for DCE-MRI in pediatric brain tumor (proven or presumptive) patients in a single MRI session.

II. To describe evolving imaging characteristics of tumor vasculature using DSC-MRI with ferumoxytol and DCE-MRI with GBCA in pediatric brain tumor patients.

SECONDARY OBJECTIVES:

Compare and evaluate magnetic resonance angiogram (MRA) with ferumoxytol between different time points.

II. To describe number and size of tumors imaged. III. To assess histology and electron microscopy (EM) on tissue samples. IV. To demonstrate differences in patients with prior therapy versus (vs.) no prior therapy (radiation and/or chemotherapy).

OUTLINE:

Patients receive ferumoxytol and gadolinium intravenously (IV) and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years.

After completion of study treatment, patients are followed up at approximately 4-6 weeks.

Conditions: Childhood Brain Neoplasm, Recurrent Childhood Brain Neoplasm
Being tested: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Ferumoxytol Non-Stoichiometric Magnetite, Gadolinium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dynamic Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery
Also called DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Undergo DCE-MRI
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery
Also called Dynamic Susceptibility Contrast-Enhanced MRI
Undergo DSC-MRI
Ferumoxytol Non-Stoichiometric MagnetiteDrug
Also called Feraheme, Ferumoxytol
Given IV
GadoliniumDrug
Also called Gd
Given IV

Study groups in NCT00978562
Study group	Role	What they receive
Diagnostic (DSC-MRI with ferumoxytol, DCE-MRI with gadolinium)	Experimental	Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years. Receives: Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging; Drug: Ferumoxytol Non-Stoichiometric Magnetite; Drug: Gadolinium

What is being measured

The primary outcome is the main question the study is designed to answer.

Vascular Properties of Pediatric Brain Tumors Using Dynamic Susceptibility-weighted Contrast Enhanced MRI (DSC-MRI) After Administration of Ferumoxytol
Signal intensity, relative cerebral blood volume (rCBV) was measured. Relative CBV measurements were calculated from regions of interest (ROI) that were placed in regions of highest perfusion seen on the rCBV color overlay parametric maps.The mean of 3 regions of contralateral white matter was used as the internal reference standard. The size of the ROIs was kept constant (radius 1.5 mm). Parametric color overlay maps were analyzed using ImageJ software (NIH, Bethesda, MD, USA).
Measured: Up to 2 years
Vascular Properties of Pediatric Brain Tumors Using Dynamic Contrast-enhanced MRI (DCE-MRI) After Administration of a Gadolinium-based Contrast Agent
Volume transfer coefficient reflecting vascular permeability of pediatric brain tumors using Dynamic Contrast-enhanced MRI (DCE-MRI) was measured. Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
Measured: up to 2 years

Secondary outcomes (5)

Histology (Only in Patients for Whom a Biopsy or Surgery is Scheduled Outside of This Protocol)
Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.
Measured: Up to 2 years
Number of Enhancing Lesions
Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.
Measured: Up to 2 years
Tumor Vascularity
Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.
Measured: Up to 2 years
Ultrastructure (Only in Patients for Whom a Biopsy or Surgery is Scheduled Outside of This Protocol)
Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.
Measured: Up to 2 years
Volume of Enhancing Lesions
Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.
Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Dec 2018

First posted17 Sep 2009 (estimated)
Study startAug 2009
Primary completionDec 2015
Study completionDec 2018

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 Childhood Brain NeoplasmStudies 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: Early Phase 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00978562
Sponsor's protocol ID: IRB00005405
Other IDs: NCI-2015-00227, 1562, 2864, SOL-09064-LX, 813, 5405, R01CA137488
Status last verified: Jul 2022
First submitted: 16 Sep 2009
Last updated: 3 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Childhood Brain Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Imaging Vascular Properties of Pediatric Brain Tumors Using DSC-MRI With Ferumoxytol (Code 7228) and DCE-MRI With Gadolinium in a Single Imaging Session: An NCI Sponsored Exploratory Trial
ClinicalTrials.gov ID: NCT00978562
Acronym / sponsor ID: IRB00005405
Conditions: Childhood Brain Neoplasm, Recurrent Childhood Brain Neoplasm
Phase: Early Phase 1
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: Aug 2009 (actual)
Primary completion: Dec 2015 (actual)
Study completion: Dec 2018 (actual)
First posted: 17 Sep 2009 (estimated)
Results: Posted 23 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To describe the vascular properties of pediatric brain tumors using ferumoxytol for DSC-MRI and GBCA for DCE-MRI in pediatric brain tumor (proven or presumptive) patients in a single MRI session.

II. To describe evolving imaging characteristics of tumor vasculature using DSC-MRI with ferumoxytol and DCE-MRI with GBCA in pediatric brain tumor patients.

SECONDARY OBJECTIVES:

Compare and evaluate magnetic resonance angiogram (MRA) with ferumoxytol between different time points.

OUTLINE:

After completion of study treatment, 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 (DSC-MRI with ferumoxytol, DCE-MRI with gadolinium)	Experimental	Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Drug: Ferumoxytol Non-Stoichiometric Magnetite, Drug: GadoliniumPatients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years.

Who may qualify

Ages: 5 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

Participant must have either radiological (presumptive) or established (proven) histological diagnosis of a brain tumor or lesion
Previously untreated participants must have a measureable lesion on an imaging study
Participants undergoing active treatment, or who have completed treatment, will have radiographic abnormalities that may or may not be recurrent tumor
Those participants requiring surgical intervention for diagnostic and/or therapeutic purposes as necessary for their disease are eligible; the tissue may be assessed by histology and/or EM for iron particles; only clinically indicated biopsy and/or surgery will be done
Participants may have had prior therapy for the primary brain tumor, including surgery, radiotherapy or chemotherapy

Key exclusion criteria (9 listed)

Participants 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
Participants with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations, are not eligible; participants with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion
Participants who are pregnant, lactating, or who suspect they might be pregnant are not eligible
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than 2.5 x upper limits of normal
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
Dynamic Contrast-Enhanced Magnetic Resonance ImagingAlso: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRIUndergo DCE-MRI	Procedure or surgery	Diagnostic (DSC-MRI with ferumoxytol, DCE-MRI with gadolinium)
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance ImagingAlso: Dynamic Susceptibility Contrast-Enhanced MRIUndergo DSC-MRI	Procedure or surgery	Diagnostic (DSC-MRI with ferumoxytol, DCE-MRI with gadolinium)
Ferumoxytol Non-Stoichiometric MagnetiteAlso: Feraheme, FerumoxytolGiven IV	Drug	Diagnostic (DSC-MRI with ferumoxytol, DCE-MRI with gadolinium)
GadoliniumAlso: GdGiven IV	Drug	Diagnostic (DSC-MRI with ferumoxytol, DCE-MRI with gadolinium)

Primary outcome

Vascular Properties of Pediatric Brain Tumors Using Dynamic Susceptibility-weighted Contrast Enhanced MRI (DSC-MRI) After Administration of Ferumoxytol
Time frame: Up to 2 years
Signal intensity, relative cerebral blood volume (rCBV) was measured. Relative CBV measurements were calculated from regions of interest (ROI) that were placed in regions of highest perfusion seen on the rCBV color overlay parametric maps.The mean of 3 regions of contralateral white matter was used as the internal reference standard. The size of the ROIs was kept constant (radius 1.5 mm). Parametric color overlay maps were analyzed using ImageJ software (NIH, Bethesda, MD, USA).
Vascular Properties of Pediatric Brain Tumors Using Dynamic Contrast-enhanced MRI (DCE-MRI) After Administration of a Gadolinium-based Contrast Agent
Time frame: up to 2 years
Volume transfer coefficient reflecting vascular permeability of pediatric brain tumors using Dynamic Contrast-enhanced MRI (DCE-MRI) was measured. Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.

5 secondary outcomes

Histology (Only in Patients for Whom a Biopsy or Surgery is Scheduled Outside of This Protocol)
Time frame: Up to 2 years
Number of Enhancing Lesions
Time frame: Up to 2 years
Tumor Vascularity
Time frame: Up to 2 years
Ultrastructure (Only in Patients for Whom a Biopsy or Surgery is Scheduled Outside of This Protocol)
Time frame: Up to 2 years
Volume of Enhancing Lesions
Time frame: Up to 2 years

Results and safety

Results posted to the registry on 23 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium)	14	12

Primary outcome: Vascular Properties of Pediatric Brain Tumors Using Dynamic Susceptibility-weighted Contrast Enhanced MRI (DSC-MRI) After Administration of Ferumoxytol

Time frame: Up to 2 years. Mean (Standard Deviation). Unit: mL/g

Measure	Ferumoxytol DSC MRI n = 7
Value	.93 (1.44)

Population analysed: 7 participants had both appropriate ferumoxytol and gadolinium scans available for analysis for this outcome.

Primary outcome: Vascular Properties of Pediatric Brain Tumors Using Dynamic Contrast-enhanced MRI (DCE-MRI) After Administration of a Gadolinium-based Contrast Agent

Time frame: up to 2 years. Mean (Standard Deviation). Unit: min^-1

Measure	Gadolinium DCE n = 7
Value	.25 (.23)

Population analysed: 7 participants had both appropriate ferumoxytol and gadolinium scans available for analysis for this outcome.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Assessed up to 2 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium)	2 of 14 (14.3%)	8 of 14 (57.1%)	1 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 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?

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 9 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 3 Aug 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2017). 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?

Vascular Properties of Pediatric Brain Tumors Using Dynamic Susceptibility-weighted Contrast Enhanced MRI (DSC-MRI) After Administration of Ferumoxytol (time frame: Up to 2 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?

On the ClinicalTrials.gov record for NCT00978562.

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 3 Aug 2022.