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Brain NeoplasmPhase 2NCT03234309

Ferumoxytol in Magnetic Resonance Imaging of Pediatric Patients With Brain Tumors

A Phase 2 study testing Ferumoxytol and Magnetic Resonance Imaging in people with Brain Neoplasm, run by OHSU Knight Cancer Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase II trial studies ferumoxytol in the magnetic resonance imaging of pediatric patients with brain tumors. Magnetic resonance imaging using ferumoxytol may help in viewing a brain tumor and blood vessels in and around the tumor in a different way than the standard gadolinium-based contrast agent. Read more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Brain Neoplasm
What is being tested?
Ferumoxytol and Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
20 Oct 2017to 30 Aug 2021
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Subjects with a presumed diagnosis of brain tumor (based on imaging) or a confirmed brain tumor (based on pathology) before or after any oncologic treatment (surgery/chemotherapy/radiation)
  • All subjects, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
  • Subjects with a calculated glomerular filtration rate (GFR) > 60 mL/min/1.73 m^2
  • Sexually active women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; surgical intervention i.e. tubal ligation or vasectomy; post-menopausal > 6 months or abstinence) for at least two months after each cycle of the study; 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

  • 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, 2009); 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 have a contraindication for 3Tesla (3T) MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material
  • Subjects with known iron overload (genetic hemochromatosis); in subjects with a family history of hemochromatosis, hemochromatosis must be ruled out prior to study entry with normal values of the following blood tests: transferrin saturation (TS) test and serum ferritin (SF) test; all associated costs will be paid by the study
  • Subject who have received ferumoxytol within 4 weeks of study entry

About this study

Official title: High Resolution Steady State Blood Volume Maps in Pediatric Brain Tumors Using MRI

This phase II trial studies ferumoxytol in the magnetic resonance imaging of pediatric patients with brain tumors. Magnetic resonance imaging using ferumoxytol may help in viewing a brain tumor and blood vessels in and around the tumor in a different way than the standard gadolinium-based contrast agent. Imaging with this experimental contrast agent may give doctors more information about tumor blood supply and the extent of the tumor itself.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Testing the superiority of ferumoxytol-based steady state (SS)-cerebral blood volume (CBV) maps over gadolinium-based contrast agent (GBCA)-based dynamic susceptibility weighted (DSC)-CBV maps in visualizing pediatric brain tumor blood volume maps.

SECONDARY OBJECTIVES:

  1. Correlation of relative cerebral blood volume (rCBV) with histology and genetic markers.

II. Assessment of therapeutic response. III. Assessment of late ferumoxytol enhancement at various stages of disease.

OUTLINE:

Patients undergo magnetic resonance imaging (MRI) with GBCA per standard of care over 45-60 minutes and then receive ferumoxytol intravenously (IV) followed by MRI over 10 minutes on day 1. Patients may optionally undergo MRI over 30 minutes without any contrast agent on day 2. Each study visit consisting of 2 days may repeat no more frequently than 4 weeks for up to 5 study visits at different stages of the disease as determined by the investigator.

After completion of study, patients are followed up at 2 and 6 weeks and then periodically for 5 years.

Conditions
Brain Neoplasm
Being tested
Ferumoxytol, Magnetic Resonance Imaging
Medical subject headings
Brain Neoplasms

What participants receive

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

  • FerumoxytolDrug

    Also called Feraheme, Ferumoxytol Non-Stoichiometric Magnetite

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI

    Undergo MRI

Study groups in NCT03234309
Study groupRoleWhat they receive
Diagnostic (ferumoxytol, MRI)ExperimentalPatients undergo MRI with GBCA per standard of care over 45-60 minutes and then receive ferumoxytol IV followed by MRI over 10 minutes on day 1. Patients may optionally undergo MRI over 30 minutes without any contrast agent on day 2. Each study visit consisting of 2 days may repeat no more frequently than 4 weeks for up to 5 study visits at different stages of the disease as determined by the investigator.
Receives: Drug: Ferumoxytol; Procedure: Magnetic Resonance Imaging

What is being measured

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

  1. Overlay accuracy with 3-dimensional anatomical T1w post contrast scans

    Ferumoxytol-based steady state-cerebral blood volume maps will be compared to gadolinium-based dynamic susceptibility weighted-cerebral blood volume maps using a 3-point scale. The mean score between the two readers will be used in the primary analyses. Inter-reader agreement will be assessed using weighted Kappa to make sure that the visualization variables are used reliably.

    Measured: Up to 5 years

  2. Confidence in identifying the lesion corresponding areas on cerebral blood volume maps

    The mean score between the two readers will be used in the primary analyses. A linear mixed effects model will be used to compare the mean of the four visualization variables between steady state and dynamic susceptibility weighted overall and at each of time points while taking into account the correlation due to repeated measures within the same patient. Inter-reader agreement will be assessed using weighted Kappa to make sure that the visualization variables are used reliably.

    Measured: Up to 5 years

  3. Cerebral blood volume in small (< 1 cm) enhancing lesions

    Ferumoxytol-based steady state-cerebral blood volume maps will be compared to gadolinium-based dynamic susceptibility weighted-cerebral blood volume maps using a 3-point scale.

    Measured: Up to 5 years

  4. Delineation of tumor from larger blood vessels

    Ferumoxytol-based steady state-cerebral blood volume maps will be compared to gadolinium-based dynamic susceptibility weighted-cerebral blood volume maps using a 3-point scale. The mean score between the two readers will be used in the primary analyses. Inter-reader agreement will be assessed using weighted Kappa to make sure that the visualization variables are used reliably.

    Measured: Up to 5 years

Secondary outcomes (6)

  1. Relative cerebral blood volume value

    Sensitivity and specificity of relative cerebral blood volume will be calculated for identifying true disease progression at different cutoff points and compare the performance between steady state and dynamic susceptibility weighted maps using McNemar's tests, and using a mixed effect logistic regression model to look at all data across different disease stages (within the same patient) if necessary and allowed by available data.

    Measured: Up to 5 years

  2. Treatment response

    For the assessment of therapeutic response, enhancing areas will be categorized as active tumor or therapy related changes based on relative cerebral blood volume values. Different cutoff points (e.g. 1.5, 1.75 and 2) will be tested for relative cerebral blood volume value from both steady state and dynamic susceptibility weighted maps, and disease status will be confirmed with subsequent magnetic resonance imaging results as recommended by Response Assessment in Neuro-Oncology Criteria or histopathology from additional surgeries ("gold standard").

    Measured: Up to 5 years

  3. Histology and genetic markers

    A linear model will be used to assess correlation of relative cerebral blood volume with histology and genetic markers based on the availability of data and type of tumor.

    Measured: Up to 5 years

  4. Ferumoxytol enhancement

    Similar models to those for primary objectives will evaluate late ferumoxytol enhancement at various stages of disease. Will be assessed on T1 and T2 weighted magnetic resonance (MR) sequences. Enhancement changes including intensity and pattern (heterogeneity) at various stages of disease will be analyzed and compared to gadolinium based contrast agent (GBCA).

    Measured: At 24 hours after administration

  5. Survival

    Data will be collected for 5 years.

    Measured: Up to 5 years

  6. Progression free survival

    Data will be collected for 5 years.

    Measured: 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.

  1. First posted31 Jul 2017
  2. Study start20 Oct 2017
  3. Primary completion30 Aug 2021
  4. Study completion30 Aug 2021

Why it stopped: No enrollments

Resources

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 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03234309
Sponsor's protocol ID
STUDY00016165
Other IDs
NCI-2017-00713, STUDY00016165
Status last verified
Nov 2021
First submitted
26 Jul 2017
Last updated
10 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ferumoxytol and Magnetic Resonance Imaging in people with Brain Neoplasm, run by OHSU Knight Cancer Institute.

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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Overlay accuracy with 3-dimensional anatomical T1w post contrast scans (time frame: Up to 5 years). The study lists 4 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 NCT03234309.

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 10 Nov 2021.

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