Clinical trial · Interventional
Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System
The Feasibility of Steady State CBV Mapping Using Ferumoxytol Immediately After Gadolinium Enhanced MRI of the CNS
NCT03270059CI-TRIAL-00104265recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
This phase II trial studies how well gadolinium and ferumoxytol magnetic resonance imaging (MRI) work in diagnosing patients with abnormalities in the central nervous system. Diagnostic procedures, such as gadolinium and ferumoxytol MRI, may help find and diagnose abnormalities in the central nervous system.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Neoplasm | Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Cranial Nerve Disorder | — | UNRESOLVED | — |
| Metastatic Malignant Neoplasm in the Brain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ferumoxytol | Drug | — | UNRESOLVED |
| Gadolinium | Drug | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (gadolinium, ferumoxytol, MRI)
- description
- Patients receive gadolinium IV and then ferumoxytol IV and undergo MRI over 60 minutes on day 1.
- interventionNames
- Drug: Ferumoxytol
- Drug: Gadolinium
- Procedure: Magnetic Resonance Imaging
- type
- EXPERIMENTAL
- label
- Group II (ferumoxytol, gadolinium, MRI)
- description
- Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1.
- interventionNames
- Drug: Ferumoxytol
- Drug: Gadolinium
- Procedure: Magnetic Resonance Imaging
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must have one of the following: * Neurological findings (i.e. headache, loss of consciousness, paresis, cranial neuropathy, seizures, etc.) * Radiological abnormalities in the brain (neoplastic or non-neoplastic in nature) * Neoplastic process elsewhere in the body that may affect the brain (i.e. possible metastasis, vascular compromise, treatment related changes, etc.) * Subjects must be able to undergo MRI imaging without anesthesia * Subjects must be at least 10 years of age * 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 * Sexually active women of child-bearing potential 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 Exclusion Criteria: * 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 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 3 weeks of study entry * Subjects with three or more drug allergies from separate drug classes
References
Publications (0)
Data not yet available
No reference posted for this study.