Status:
TERMINATED
Ferumoxytol- and Gadolinium-Labeled MRI in Measuring Tumors Before or After Treatment in Patients With Primary or Metastatic Brain Tumors
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Oregon Health and Science University
Conditions:
Metastatic Malignant Neoplasm in the Brain
Primary Brain Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well magnetic resonance imaging (MRI) using contrast imaging agent ferumoxytol works in comparison to standard imaging agent gadolinium in measuring tumors in patients ...
Detailed Description
PRIMARY OBJECTIVES: I. To compare quantitative blood brain barrier permeability measurements (derived transfer coefficient \[Ktrans\]) of a standard gadolinium (Gd) MRI contrast agent at 3T and 7T us...
Eligibility Criteria
Inclusion
- Subjects with radiographically suspected, histologically or cytologically confirmed primary brain tumors or brain metastasis are eligible
- Subjects may be enrolled at any point in diagnosis or treatment
- Subjects must have had radiographically evaluable or measurable disease with standard magnetic resonance (MR) imaging
- Members of all races and ethnic groups will be included
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 3 (Karnofsky performance status \[KPS\] \>= 30)
- Ability to understand and the willingness to sign a written informed consent document, or have a representative able to consent for the subject
- Sexually active women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study treatment and for the duration of study treatment; should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Subject agrees to complete follow up visit
Exclusion
- 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
- Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, need monitored anesthesia for scanning, or have an allergy to Gd contrast material
- Subjects with known hepatic insufficiency or cirrhosis
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ferumoxytol
- Subjects with known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions)
- Subjects expecting to undergo surgery between the imaging sessions; subjects may undergo surgery at any time before the first, or after the last imaging session; this exclusion only applies to each study visit (3 day scanning session), and does not apply to the time (at least 3 weeks) between each study visit
- Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or lactating women are excluded from this study
- Inability or unwillingness to undergo the complete series of imaging sessions; inability or unwillingness to complete the one month follow-up
- Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible
- Subjects with glomerular filtration rate (GFR) \< 50
- Subjects with three or more drug allergies from separate drug classes
Key Trial Info
Start Date :
November 16 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00659126
Start Date
November 16 2006
End Date
December 31 2020
Last Update
September 7 2023
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239