Brain InjuryEarly Phase 1NCT02452216
Using Ferumoxytol-Enhanced MRI to Measure Inflammation in Patients With Brain Tumors or Other Conditions of the CNS
A Early Phase 1 study testing Ferumoxytol, Tissue Analysis and Magnetic Resonance Imaging in people with Brain Injury and Central Nervous System Degenerative Disorder, run by Michael Iv at 1 site in United States.
Trial summary
This pilot clinical trial study will assess the inflammatory response of brain tumors or other central nervous system conditions in pediatric and adult patients using ferumoxytol-enhanced MRI. Imaging features will be correlated with the number of inflammatory cells (macrophages) at histopathology. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Brain Injury, Central Nervous System Degenerative Disorder, Central Nervous System Infectious Disorder
- What is being tested?
- Ferumoxytol, Tissue Analysis and 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2015to 12 Jan 2017
- 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 brain tumor diagnosed by MRI
- Patients undergoing neuro-imaging evaluation by the neurosurgical service for other indications (e.g. vascular malformations, traumatic brain injury, ischemic and hemorrhagic stroke, CNS infections, and neuro-degenerative diseases)
Who cannot join
- Informed consent cannot be obtained either from the patient or legal representative
- Severe coexisting or terminal systemic disease that limits life expectancy or that may interfere with the conduct of the study
- Contraindication to MRI (metal implants)
- Hemosiderosis/hemochromatosis
- Need for sedation or anesthesia (claustrophobia) that will not otherwise be undertaken as part of routine clinical care (e.g. routine MRI under sedation already planned)
- Known hypersensitivity to Feraheme (ferumoxytol) or any of its components
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Hospitals and Clinics
Stanford, California, 94305
About this study
Official title: MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI
This pilot clinical trial study will assess the inflammatory response of brain tumors or other central nervous system conditions in pediatric and adult patients using ferumoxytol-enhanced MRI. Imaging features will be correlated with the number of inflammatory cells (macrophages) at histopathology. Determining the extent of inflammation associated with pathologies in the central nervous system may be helpful for diagnostic and prognostic purposes as well as monitoring treatment response of current and future immunotherapies.
Read the detailed description
In this study, we will establish the MR imaging characteristics of macrophages in malignant brain tumors and other CNS conditions in the pediatric and adult populations using ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle that is approved for the treatment of iron deficiency anemia in patients with chronic kidney disease. The investigators will correlate the MR signal of ferumoxytol uptake with the number of macrophages in surgical specimen at histopathology. This information may potentially offer clinicians a new means for risk stratification and monitoring treatment efficacy.
- Conditions
- Brain Injury, Central Nervous System Degenerative Disorder, Central Nervous System Infectious Disorder, Central Nervous System Vascular Malformation, Hemorrhagic Cerebrovascular Accident, Ischemic Cerebrovascular Accident
- Being tested
- Ferumoxytol, Tissue Analysis, Magnetic Resonance Imaging
- Medical subject headings
- Brain Injuries, Neurodegenerative Diseases, Central Nervous System Infections, Central Nervous System Vascular Malformations, Hemorrhagic Stroke, Ischemic Stroke, 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
Undergo ferumoxytol-enhanced MRI
Tissue AnalysisOther
Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, MRI
All subjects in the experimental arm who undergo ferumoxytol infusion will subsequently have MRI.
| Study group | Role | What they receive |
|---|---|---|
| Ferumoxytol group | 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: Drug: Ferumoxytol; Other: Tissue Analysis; Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain measurements of iron concentration (indicative of ferumoxytol uptake) on T2*-weighted MR images.
Measured: Day 1
Secondary outcomes (1)
Determine the number of macrophages in resected/biopsied 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 posted22 May 2015 (estimated)
- Study start10 Jun 2015
- Primary completion12 Jan 2017
- Study completion12 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Iv
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Iv, Stanford University
- Investigators
- Michael Iv, MD, Principal investigator, Stanford University Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452216
- Sponsor's protocol ID
- BRNCNS0007
- Other IDs
- NCI-2015-00435, 26570
- Status last verified
- Aug 2017
- First submitted
- 20 May 2015
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. 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
- ClinicalTrials.gov ID
- NCT02452216
- Acronym / sponsor ID
- BRNCNS0007
- Conditions
- Brain Injury, Central Nervous System Degenerative Disorder, Central Nervous System Infectious Disorder, Central Nervous System Vascular Malformation, Hemorrhagic Cerebrovascular Accident, Ischemic Cerebrovascular Accident
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Michael IvUniversity, hospital or other
- Study start
- 10 Jun 2015 (actual)
- Primary completion
- 12 Jan 2017 (actual)
- Study completion
- 12 Jan 2017 (actual)
- First posted
- 22 May 2015 (estimated)
- 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 clinical trial study will assess the inflammatory response of brain tumors or other central nervous system conditions in pediatric and adult patients using ferumoxytol-enhanced MRI. Imaging features will be correlated with the number of inflammatory cells (macrophages) at histopathology. Determining the extent of inflammation associated with pathologies in the central nervous system may be helpful for diagnostic and prognostic purposes as well as monitoring treatment response of current and future immunotherapies.
Detailed description
In this study, we will establish the MR imaging characteristics of macrophages in malignant brain tumors and other CNS conditions in the pediatric and adult populations using ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle that is approved for the treatment of iron deficiency anemia in patients with chronic kidney disease. The investigators will correlate the MR signal of ferumoxytol uptake with the number of macrophages in surgical specimen at histopathology. This information may potentially offer clinicians a new means for risk stratification and monitoring treatment efficacy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ferumoxytol group | Experimental | Drug: Ferumoxytol, Other: Tissue Analysis, Procedure: Magnetic Resonance ImagingAll 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 (2 listed)
- Any patient with suspected brain tumor diagnosed by MRI
- Patients undergoing neuro-imaging evaluation by the neurosurgical service for other indications (e.g. vascular malformations, traumatic brain injury, ischemic and hemorrhagic stroke, CNS infections, and neuro-degenerative diseases)
Key exclusion criteria (7 listed)
- Informed consent cannot be obtained either from the patient or legal representative
- Severe coexisting or terminal systemic disease that limits life expectancy or that may interfere with the conduct of the study
- Contraindication to MRI (metal implants)
- Hemosiderosis/hemochromatosis
- Need for sedation or anesthesia (claustrophobia) that will not otherwise be undertaken as part of routine clinical care (e.g. routine MRI under sedation already planned)
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 |
|---|---|---|
| FerumoxytolAlso: Feraheme, FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITEUndergo ferumoxytol-enhanced MRI | Drug | Ferumoxytol group |
| Tissue AnalysisCorrelative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion. | Other | Ferumoxytol group |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, MRIAll subjects in the experimental arm who undergo ferumoxytol infusion will subsequently have MRI. | Procedure or surgery | Ferumoxytol group |
Primary outcome
Obtain measurements of iron concentration (indicative of ferumoxytol uptake) on T2*-weighted MR images.
Time frame: Day 1
1 secondary outcome
Determine the number of macrophages in resected/biopsied samples at histopathology.
Time frame: Days 2-4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- 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, MD principal investigator
Stanford University Hospitals and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ferumoxytol, Tissue Analysis and Magnetic Resonance Imaging in people with Brain Injury and Central Nervous System Degenerative Disorder, run by Michael Iv 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 2 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: finished, as of the sponsor's last update on 31 Aug 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Obtain measurements of iron concentration (indicative of ferumoxytol uptake) on T2*-weighted MR images. (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 31 Aug 2017.