Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System

NCT03270059 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY00017028NCI-2017-01460
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Visualization of normal vasculature

  Primary analysis will use the average score of the two readers. The mean difference and the associated 95% confidence interval (CI) between the two groups will be estimated using a linear regression model. Equivalence will be claimed if the 95% CI does not include 0.4 on either side (equivalence margin is 0.4).

  Up to 5 years

• Visualization of abnormal vasculature

  Primary analysis will use the average score of the two readers. The mean difference and the associated 95% CI between the two groups will be estimated using a linear regression model. Equivalence will be claimed if the 95% CI does not include 0.4 on either side (equivalence margin is 0.4).

  Up to 5 years

• Visualization of normal anatomical structures

  Primary analysis will use the average score of the two readers. The mean difference and the associated 95% CI between the two groups will be estimated using a linear regression model. Equivalence will be claimed if the 95% CI does not include 0.4 on either side (equivalence margin is 0.4).

  Up to 5 years

• Identification of the lesion corresponding areas on cerebral blood volume (CBV) maps

  Will assess the confidence in identifying the lesion corresponding areas on CBV maps as well as signal change (deltaR2\*) and relative cerebral blood volume. Primary analysis will use the average score of the two readers. The mean difference and the associated 95% CI between the two groups will be estimated using a linear regression model. Equivalence will be claimed if the 95% CI does not include 0.4 on either side (equivalence margin is 0.4).

  Up to 5 years

Secondary Outcomes (3)

• Contrast enhancement

  Up to 5 years

• Border delineation

  Up to 5 years

• Internal morphology

  Up to 5 years

Study Arms (2)

Group I (gadolinium, ferumoxytol, MRI)

EXPERIMENTAL

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

Drug: Ferumoxytol; Drug: Gadolinium; Procedure: Magnetic Resonance Imaging

Group II (ferumoxytol, gadolinium, MRI)

EXPERIMENTAL

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

Drug: Ferumoxytol; Drug: Gadolinium; Procedure: Magnetic Resonance Imaging

Interventions

Ferumoxytol DRUG

Given IV

Also known as: Feraheme, Ferumoxytol Non-Stoichiometric Magnetite

Group I (gadolinium, ferumoxytol, MRI); Group II (ferumoxytol, gadolinium, MRI)

Gadolinium DRUG

Given IV

Also known as: Gd

Group I (gadolinium, ferumoxytol, MRI); Group II (ferumoxytol, gadolinium, MRI)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Group I (gadolinium, ferumoxytol, MRI); Group II (ferumoxytol, gadolinium, MRI)

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene Corporation: collaborator
• Oregon Health and Science University: collaborator
• OHSU Knight Cancer Institute: lead

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Central Nervous System Neoplasms; Cranial Nerve Diseases; Brain Neoplasms

Interventions

Ferrosoferric Oxide; Gadolinium; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Lanthanoid Series Elements; Metals, Rare Earth; Elements; Metals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Michael F Regner, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy E Huddleston, MPA:HA, CCRP

CONTACT

5034942910; huddlesa@ohsu.edu

Lisa C Muir, MPA:HA, CCRP

CONTACT

5034942910; bennetli@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 1, 2017
• Study Start: October 6, 2017
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)