Clinical trial · Interventional
In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI
MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI (Pediatric Brain Tumor Protocol)
NCT03179449CI-TRIAL-00065650withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Accrual Factor
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Brain Neoplasm | Childhood Brain Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic (ferumoxytol-enhanced MRI) | Diagnostic Test | — | UNRESOLVED |
| Ferumoxytol | Drug | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
| Tissue Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (ferumoxytol-enhanced MRI)
- description
- 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.
- interventionNames
- Diagnostic Test: Diagnostic (ferumoxytol-enhanced MRI)
- Procedure: Surgery
- Drug: Ferumoxytol
- Other: Tissue Analysis
Primary outcomes (1)
- measure
- Iron concentration measurements
- timeFrame
- Day 1
- description
- Obtain susceptibility measurements and relaxation times (R2, R2\*, R2') in patients receiving ferumoxytol.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient with suspected malignant brain tumor on diagnostic MR imaging who will undergo a resection Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.