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

NCT ID: NCT03270059

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-06
• Study Completion Date: 2027-08-15

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To test if prior gadolinium administration affects vascular imaging using ferumoxytol.

II. To test signal changes of T2*w multi-echo fast field echo (mFFE) scans before and after contrast agent injection.

SECONDARY OBJECTIVES:

I. To test if ferumoxytol affects gadolinium enhanced MRI. II. To test if steady state cerebral blood volume (CBV) maps are different at various magnetic field strengths.

EXPLORATORY OBJECTIVES:

I. To explore late ferumoxytol enhancement (optional MRI) hours to days after ferumoxytol administration in various brain pathologies.

II. To evaluate the effects of ferumoxytol on malignant and non-malignant lesions in head & neck, and liver lesions

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients receive gadolinium intravenously (IV) and then ferumoxytol IV and undergo MRI over 60 minutes on day 1.

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

Conditions

Central Nervous System Neoplasm; Cranial Nerve Disorder; Metastatic Malignant Neoplasm in the Brain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Group I (gadolinium, ferumoxytol, MRI)

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

Group Type: EXPERIMENTAL

Ferumoxytol

Intervention Type: DRUG

Given IV

Gadolinium

Intervention Type: DRUG

Given IV

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo MRI

Group II (ferumoxytol, gadolinium, MRI)

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

Group Type: EXPERIMENTAL

Ferumoxytol

Intervention Type: DRUG

Given IV

Gadolinium

Intervention Type: DRUG

Given IV

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo MRI

Interventions

Ferumoxytol

Given IV

Intervention Type: DRUG

Gadolinium

Given IV

Intervention Type: DRUG

Magnetic Resonance Imaging

Undergo MRI

Intervention Type: PROCEDURE

Other Intervention Names

Feraheme; Ferumoxytol Non-Stoichiometric Magnetite; Gd; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR Imaging; MRI; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging

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

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Michael F. Regner, M.D., M.S.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael F Regner, MD

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amy E Huddleston, MPA:HA, CCRP

Role: CONTACT

huddlesa@ohsu.edu

5034942910

Lisa C Muir, MPA:HA, CCRP

Role: CONTACT

bennetli@ohsu.edu

5034942910

Facility Contacts

Michael F Regner

Role: primary

regnerm@ohsu.edu

503-418-0990

Other Identifiers

NCI-2017-01460

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00017028

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00017028

Identifier Type: -

Identifier Source: org_study_id