Status:
COMPLETED
DSC-MRI With Ferumoxytol and DCE-MRI With Gadolinium in Imaging Vascular Properties in Younger Patients With Brain Tumors
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Childhood Brain Neoplasm
Recurrent Childhood Brain Neoplasm
Eligibility:
All Genders
5-18 years
Phase:
EARLY_PHASE1
Brief Summary
This clinical trial studies dynamic susceptibility-weighted contrast enhanced magnetic resonance imaging (DSC-MRI) after administration of ferumoxytol and dynamic contrast-enhanced MRI (DCE-MRI) after...
Detailed Description
PRIMARY OBJECTIVES: I. To describe the vascular properties of pediatric brain tumors using ferumoxytol for DSC-MRI and GBCA for DCE-MRI in pediatric brain tumor (proven or presumptive) patients in a ...
Eligibility Criteria
Inclusion
- Participant must have either radiological (presumptive) or established (proven) histological diagnosis of a brain tumor or lesion
- Previously untreated participants must have a measureable lesion on an imaging study
- Participants undergoing active treatment, or who have completed treatment, will have radiographic abnormalities that may or may not be recurrent tumor
- Those participants requiring surgical intervention for diagnostic and/or therapeutic purposes as necessary for their disease are eligible; the tissue may be assessed by histology and/or EM for iron particles; only clinically indicated biopsy and/or surgery will be done
- Participants may have had prior therapy for the primary brain tumor, including surgery, radiotherapy or chemotherapy
- After entry into the study, participants agree to be followed for up to 6 weeks after the final infusion of ferumoxytol
- All participants, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
- Baseline MRI studies for participants receiving ferumoxytol must be performed within 16 weeks of study entry
- Sexually active women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; 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
Exclusion
- Participants 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
- Participants with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations, are not eligible; participants with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion
- Participants who are pregnant, lactating, or who suspect they might be pregnant are not eligible
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than 2.5 x upper limits of normal
- Glomerular filtration rate (GFR) \< 50
- Participants 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 GBCA
- Participants with known hepatic insufficiency or cirrhosis
- Human immunodeficiency virus (HIV)-positive participants on combination antiretroviral therapy are ineligible
- Participants that have a known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions)
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00978562
Start Date
August 1 2009
End Date
December 1 2018
Last Update
August 3 2022
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239