IRB #

STUDY00017028

Title

The feasibility of Steady state CBV mapping using ferumoxytol immediately after Gadolinium enhanced MRI of the CNS

Principal Investigator

Edward Neuwelt

Study Purpose

The goal of the study is to test if steady state CBV mapping with ferumoxytol is feasible shortly after gadolinium enhanced MRI. The study will assess if there are confounding effects of the two contrast agents when both are administered during the same imaging session.

Medical Condition(s)

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).

Eligibility Criteria

1. 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).
2. Subjects must be able to undergo MRI imaging without anesthesia.
3. Subjects must be at least 10 years of age.
4. All subjects, or their legal guardians, must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
5. Subjects with a calculated GFR > 60 mL/min/1.73 m2. (Calculation must be done using the National Kidney Disease Education Program’s website http://nkdep.nih.gov/lab-evaluation/gfr-calculators/adults-conventional-unit.asp )
6. 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.

Age Range

10 - 90

Healthy Volunteers Needed

No

Duration of Participation

Subject may complete a total of 5 study visits consisting of at least 1 day of imaging within 5 years of enrollment.

Minors Included

Yes

Contact

Research Nurse Jenny Firkins, RN
503-494-5626
firkinsj@ohsu.edu

Sponsor

Recruitment End

12/30/2022

Compensation Provided

No


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