NCT03270059 Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System
| NCT ID | NCT03270059 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | OHSU Knight Cancer Institute |
| Condition | Central Nervous System Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2017-10-06 |
| Primary Completion | 2027-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2017-10-06 with a primary completion date of 2027-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Michael F Regner, MD
PRINCIPAL INVESTIGATOR
OHSU Knight Cancer Institute
Frequently Asked Questions
Who can join the NCT03270059 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, studying Central Nervous System Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03270059 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03270059 currently recruiting?
Yes, NCT03270059 is actively recruiting participants. Contact the research team at huddlesa@ohsu.edu for enrollment information.
Where is the NCT03270059 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT03270059 clinical trial?
NCT03270059 is sponsored by OHSU Knight Cancer Institute. The principal investigator is Michael F Regner, MD at OHSU Knight Cancer Institute. The trial plans to enroll 150 participants.