Recruiting
Phase 2

Gadolinium & Ferumoxytol

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT03270059

Conditions

Central Nervous System Neoplasm

Cranial Nerve Disorder

Metastatic Malignant Neoplasm in the Brain

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

Interventions

Ferumoxytol

Gadolinium

Magnetic Resonance Imaging

Study Details

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.

Conditions

Central Nervous System Neoplasm

Cranial Nerve Disorder

Metastatic Malignant Neoplasm in the Brain

Study ID

NCT03270059

Start date

Oct 6, 2017

Status verified date

Feb, 2026

Completion date

Dec 15, 2028

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Group I (gadolinium, ferumoxytol, MRI)

Patients receive gadolinium IV and then ferumoxytol IV and undergo MRI over 60 minutes on day 1.

experimental: Group II (ferumoxytol, gadolinium, MRI)

Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1.

Interventions

Ferumoxytol

Given IV

Gadolinium

Given IV

Magnetic Resonance Imaging

Undergo MRI

Primary outcome measure

  • Visualization of normal vasculature [ Time Frame: Up to 5 years ]
  • Visualization of abnormal vasculature [ Time Frame: Up to 5 years ]
  • Visualization of normal anatomical structures [ Time Frame: Up to 5 years ]
  • Identification of the lesion corresponding areas on cerebral blood volume (CBV) maps [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Amy E Huddleston, MPA:HA, CCRP

5034942910huddlesa@ohsu.edu

Lisa C Muir, MPA:HA, CCRP

5034942910bennetli@ohsu.edu

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Ramon Barajas, MD

503-418-0990barajas@ohsu.edu

Principal Investigator:

Ramon Barajas, MD

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2026-02-27.