Childhood Brain NeoplasmEarly Phase 1NCT03179449
In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI
A Early Phase 1 study testing Diagnostic (ferumoxytol-enhanced MRI), Surgery and Ferumoxytol in people with Childhood Brain Neoplasm, run by Michael Iv.
Trial summary
This pilot early phase I trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) correlates with inflammatory (macrophage) responses in pediatric patients with malignant brain tumors. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Childhood Brain Neoplasm
- What is being tested?
- Diagnostic (ferumoxytol-enhanced MRI), Surgery and Ferumoxytol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 1 Jun 2025
- Phase
- Early Phase 1
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient with suspected malignant brain tumor on diagnostic MR imaging who will undergo a resection
Who cannot join
- Informed consent cannot be obtained either from the patient or legal representative
- Severe coexisting or terminal systemic disease that may interfere with the conduct of the study
- Contraindication to MRI (metal implants)
- Hemosiderosis/hemochromatosis
- Iron overload from any cause (not just hemosiderosis or hemochromatosis), even if secondary to frequent blood transfusions, severe chronic hemolysis, excess dietary or parenteral iron, or any other etiology
- Known hypersensitivity to ferumoxytol or any of its components
- Pregnant patients
About this study
Official title: MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI (Pediatric Brain Tumor Protocol)
This pilot early phase I trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) correlates with inflammatory (macrophage) responses in pediatric patients with malignant brain tumors. If there is good correlation, ferumoxytol-enhanced MRI can serve as a noninvasive imaging biomarker of inflammation.
Read the detailed description
PRIMARY OBJECTIVE:
- To establish the magnetic resonance (MR) imaging signal characteristics of macrophages in pediatric patients (>= 2 years old) with newly diagnosed malignant brain tumors using ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle.
SECONDARY OBJECTIVES:
- To correlate the MRI signal of ferumoxytol uptake in macrophages with the number of macrophages in surgical tumor specimen at histopathology.
OUTLINE:
Patients receive a single intravenous infusion of ferumoxytol over 15 minutes. After 24 hours, patients undergo ferumoxytol-enhanced magnetic resonance imaging (MRI). Patients will then undergo MRI-localized tissue sampling and tumor resection.
- Conditions
- Childhood Brain Neoplasm
- Being tested
- Diagnostic (ferumoxytol-enhanced MRI), Surgery, Ferumoxytol, Tissue Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic (ferumoxytol-enhanced MRI)Diagnostic test
Also called CONTRAST ENHANCED MRI, Contrast-enhanced MRI
Undergo ferumoxytol-enhanced MRI
SurgeryProcedure or surgery
Undergo surgical resection
FerumoxytolDrug
Also called Feraheme, FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE
Given IV
Tissue AnalysisOther
Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (ferumoxytol-enhanced MRI) | Experimental | All subjects in the experimental arm will have a single intravenous dose of ferumoxytol (5 mg Fe/kg), to be administered 24 hours before the subject undergoes ferumoxytol-enhanced magnetic resonance imaging (MRI). These subjects will subsequently undergo surgery, and tissue analysis of surgically resected samples (specifically the number of iron-containing and non-iron-containing macrophages) will be correlated with imaging features on ferumoxytol-enhanced MRI. Receives: Diagnostic Test: Diagnostic (ferumoxytol-enhanced MRI); Procedure: Surgery; Drug: Ferumoxytol; Other: Tissue Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron concentration measurements
Obtain susceptibility measurements and relaxation times (R2, R2*, R2') in patients receiving ferumoxytol.
Measured: Day 1
Secondary outcomes (1)
Macrophages on histopathology
Determine the number of macrophages in tissue samples at histopathology.
Measured: Days 2-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Jul 2017
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Why it stopped: Accrual Factor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Brain NeoplasmStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Iv
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Michael Iv, Stanford University
- Investigators
- Michael Iv, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179449
- Sponsor's protocol ID
- IRB-39245
- Other IDs
- NCI-2017-00959, PEDSBRNCNS0008, P30CA124435, PEDSBRNCNS0008
- Status last verified
- Apr 2023
- First submitted
- 5 Jun 2017
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI (Pediatric Brain Tumor Protocol)
- ClinicalTrials.gov ID
- NCT03179449
- Acronym / sponsor ID
- IRB-39245
- Conditions
- Childhood Brain Neoplasm
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Accrual Factor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Michael IvUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot early phase I trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) correlates with inflammatory (macrophage) responses in pediatric patients with malignant brain tumors. If there is good correlation, ferumoxytol-enhanced MRI can serve as a noninvasive imaging biomarker of inflammation.
Detailed description
PRIMARY OBJECTIVE:
- To establish the magnetic resonance (MR) imaging signal characteristics of macrophages in pediatric patients (>= 2 years old) with newly diagnosed malignant brain tumors using ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle.
SECONDARY OBJECTIVES:
- To correlate the MRI signal of ferumoxytol uptake in macrophages with the number of macrophages in surgical tumor specimen at histopathology.
OUTLINE:
Patients receive a single intravenous infusion of ferumoxytol over 15 minutes. After 24 hours, patients undergo ferumoxytol-enhanced magnetic resonance imaging (MRI). Patients will then undergo MRI-localized tissue sampling and tumor resection.
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-enhanced MRI) | Experimental | Diagnostic Test: Diagnostic (ferumoxytol-enhanced MRI), Procedure: Surgery, Drug: Ferumoxytol, Other: Tissue AnalysisAll subjects in the experimental arm will have a single intravenous dose of ferumoxytol (5 mg Fe/kg), to be administered 24 hours before the subject undergoes ferumoxytol-enhanced magnetic resonance imaging (MRI). These subjects will subsequently undergo surgery, and tissue analysis of surgically resected samples (specifically the number of iron-containing and non-iron-containing macrophages) will be correlated with imaging features on ferumoxytol-enhanced MRI. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient with suspected malignant brain tumor on diagnostic MR imaging who will undergo a resection
Key exclusion criteria (7 listed)
- Informed consent cannot be obtained either from the patient or legal representative
- Severe coexisting or terminal systemic disease that may interfere with the conduct of the study
- Contraindication to MRI (metal implants)
- Hemosiderosis/hemochromatosis
- Iron overload from any cause (not just hemosiderosis or hemochromatosis), even if secondary to frequent blood transfusions, severe chronic hemolysis, excess dietary or parenteral iron, or any other etiology
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 |
|---|---|---|
| Diagnostic (ferumoxytol-enhanced MRI)Also: CONTRAST ENHANCED MRI, Contrast-enhanced MRIUndergo ferumoxytol-enhanced MRI | Diagnostic test | Diagnostic (ferumoxytol-enhanced MRI) |
| SurgeryUndergo surgical resection | Procedure or surgery | Diagnostic (ferumoxytol-enhanced MRI) |
| FerumoxytolAlso: Feraheme, FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITEGiven IV | Drug | Diagnostic (ferumoxytol-enhanced MRI) |
| Tissue AnalysisCorrelative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion. | Other | Diagnostic (ferumoxytol-enhanced MRI) |
Primary outcome
Iron concentration measurements
Time frame: Day 1
Obtain susceptibility measurements and relaxation times (R2, R2*, R2') in patients receiving ferumoxytol.
1 secondary outcome
Macrophages on histopathology
Time frame: Days 2-4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Michael Iv principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Diagnostic (ferumoxytol-enhanced MRI), Surgery and Ferumoxytol in people with Childhood Brain Neoplasm, run by Michael Iv.
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 1 inclusion and 7 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 14 Apr 2023. 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?
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?
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?
Iron concentration measurements (time frame: Day 1). 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 14 Apr 2023.