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

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ClinicalTrials.gov Identifier: NCT03270059
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : September 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Edward Neuwelt, OHSU Knight Cancer Institute

Brief Summary:
This randomized phase II trial studies how well gadolinium and ferumoxytol magnetic resonance imaging (MRI) works 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.

Condition or disease Intervention/treatment Phase
Central Nervous System Neoplasm Cranial Nerve Disorder Loss of Consciousness Paresis Drug: Ferumoxytol Drug: Gadolinium Procedure: Magnetic Resonance Imaging Phase 2

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.

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

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.

After completion of study, patients are followed up at 2 and 6 weeks.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Feasibility of Steady State CBV Mapping Using Ferumoxytol Immediately After Gadolinium Enhanced MRI of the CNS
Actual Study Start Date : October 6, 2017
Estimated Primary Completion Date : August 15, 2022
Estimated Study Completion Date : August 15, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Ferumoxytol

Arm Intervention/treatment
Experimental: Group I (gadolinium, ferumoxytol, MRI)
Patients receive gadolinium IV and then ferumoxytol IV and undergo MRI over 60 minutes on day 1.
Drug: Ferumoxytol
Given IV

Drug: Gadolinium
Given IV

Procedure: Magnetic Resonance Imaging
Undergo MRI

Experimental: Group II (ferumoxytol, gadolinium, MRI)
Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1.
Drug: Ferumoxytol
Given IV

Drug: Gadolinium
Given IV

Procedure: Magnetic Resonance Imaging
Undergo MRI




Primary Outcome Measures :
  1. Identification of the lesion corresponding areas on cerebral blood volume (CBV) maps [ Time Frame: Up to 6 weeks ]
    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).

  2. Visualization of abnormal vasculature [ Time Frame: Up to 6 weeks ]
    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).

  3. Visualization of normal anatomical structures [ Time Frame: Up to 6 weeks ]
    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).

  4. Visualization of normal vasculature [ Time Frame: Up to 6 weeks ]
    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).


Secondary Outcome Measures :
  1. Border delineation [ Time Frame: Up to 6 weeks ]
    The mean difference and the associated 95% CI before versus after ferumoxytol in the three visualization variables will be estimated using a paired t-test based on the average score of the two readers. Will use the same equivalence margin of 0.4. To compare the two magnetic field strengths, will also use a linear regression model to analyze contrast to noise ratios, Image homogeneity and susceptibility artifacts (the latter two based on average score of the two readers).

  2. Contrast enhancement [ Time Frame: Up to 6 weeks ]
    The mean difference and the associated 95% CI before versus after ferumoxytol in the three visualization variables will be estimated using a paired t-test based on the average score of the two readers. Will use the same equivalence margin of 0.4. To compare the two magnetic field strengths, will also use a linear regression model to analyze contrast to noise ratios, Image homogeneity and susceptibility artifacts (the latter two based on average score of the two readers).

  3. Internal morphology [ Time Frame: Up to 6 weeks ]
    The mean difference and the associated 95% CI before versus after ferumoxytol in the three visualization variables will be estimated using a paired t-test based on the average score of the two readers. Will use the same equivalence margin of 0.4. To compare the two magnetic field strengths, will also use a linear regression model to analyze contrast to noise ratios, Image homogeneity and susceptibility artifacts (the latter two based on average score of the two readers).



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have neurological findings (i.e. loss of consciousness, paresis, cranial neuropathy, etc.), and/or radiological abnormalities in the brain (neoplastic or non-neoplastic in nature)
  • Subjects must be able to undergo MRI imaging without anesthesia
  • 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
  • Subjects with a calculated glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270059


Locations
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United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Edward A. Neuwelt    503-494-5626    neuwelte@ohsu.edu   
Principal Investigator: Edward A. Neuwelt         
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Edward Neuwelt OHSU Knight Cancer Institute

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Responsible Party: Edward Neuwelt, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT03270059     History of Changes
Other Study ID Numbers: STUDY00017028
NCI-2017-01460 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
STUDY00017028 ( Other Identifier: OHSU Knight Cancer Institute )
P30CA069533 ( U.S. NIH Grant/Contract )
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Paresis
Nervous System Neoplasms
Central Nervous System Neoplasms
Unconsciousness
Cranial Nerve Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neoplasms by Site
Neoplasms
Consciousness Disorders
Neurobehavioral Manifestations
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions