DSC-MRI With Ferumoxytol and DCE-MRI With Gadolinium in Imaging Vascular Properties in Younger Patients With Brain Tumors

NCT00978562 | Completed Early Phase 1 Results DMC

• 8 other identifiers: IRB00005405NCI-2015-0022715622864SOL-09064-LX8135405R01CA137488
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 administration of a gadolinium-based contrast agent (GBCA) in viewing the vessels of the brain in younger patients with brain tumors. Ferumoxytol is an experimental form of very small iron particles that are taken by the blood stream to cells adjacent and inside the tumor. These iron particles may make it easier to see the areas of the brain that are affected by tumor. Ferumoxytol may work better than standard GBCA in viewing the vessels of the brain and brain tumor on MRI. Using ferumoxytol and GBCA in the same MRI session may provide more information about tumor blood supply and the extent of the tumor.

Conditions

Childhood Brain Neoplasm; Recurrent Childhood Brain Neoplasm

Outcome Measures

Primary Outcomes (2)

• Vascular Properties of Pediatric Brain Tumors Using Dynamic Susceptibility-weighted Contrast Enhanced MRI (DSC-MRI) After Administration of Ferumoxytol

  Signal intensity, relative cerebral blood volume (rCBV) was measured. Relative CBV measurements were calculated from regions of interest (ROI) that were placed in regions of highest perfusion seen on the rCBV color overlay parametric maps.The mean of 3 regions of contralateral white matter was used as the internal reference standard. The size of the ROIs was kept constant (radius 1.5 mm). Parametric color overlay maps were analyzed using ImageJ software (NIH, Bethesda, MD, USA).

  Up to 2 years

• Vascular Properties of Pediatric Brain Tumors Using Dynamic Contrast-enhanced MRI (DCE-MRI) After Administration of a Gadolinium-based Contrast Agent

  Volume transfer coefficient reflecting vascular permeability of pediatric brain tumors using Dynamic Contrast-enhanced MRI (DCE-MRI) was measured. Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.

  up to 2 years

Secondary Outcomes (5)

• Histology (Only in Patients for Whom a Biopsy or Surgery is Scheduled Outside of This Protocol)

  Up to 2 years

• Number of Enhancing Lesions

  Up to 2 years

• Tumor Vascularity

  Up to 2 years

• Ultrastructure (Only in Patients for Whom a Biopsy or Surgery is Scheduled Outside of This Protocol)

  Up to 2 years

• Volume of Enhancing Lesions

  Up to 2 years

Study Arms (1)

Diagnostic (DSC-MRI with ferumoxytol, DCE-MRI with gadolinium)

EXPERIMENTAL

Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years.

Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging; Drug: Ferumoxytol Non-Stoichiometric Magnetite; Drug: Gadolinium

Interventions

Dynamic Contrast-Enhanced Magnetic Resonance Imaging PROCEDURE

Undergo DCE-MRI

Also known as: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI

Diagnostic (DSC-MRI with ferumoxytol, DCE-MRI with gadolinium)

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging PROCEDURE

Undergo DSC-MRI

Also known as: Dynamic Susceptibility Contrast-Enhanced MRI

Diagnostic (DSC-MRI with ferumoxytol, DCE-MRI with gadolinium)

Ferumoxytol Non-Stoichiometric Magnetite DRUG

Given IV

Also known as: Feraheme, Ferumoxytol

Diagnostic (DSC-MRI with ferumoxytol, DCE-MRI with gadolinium)

Gadolinium DRUG

Given IV

Also known as: Gd

Diagnostic (DSC-MRI with ferumoxytol, DCE-MRI with gadolinium)

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

Ferrosoferric Oxide; Gadolinium

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Lanthanoid Series Elements; Metals, Rare Earth; Elements; Metals

Results Point of Contact

• Title: Edward Neuwelt, MD
• Organization: OHSU KCI

huddlesa@ohsu.edu

503-494-5626

Study Officials

• Edward Neuwelt

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 17, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2018
• Last Updated: August 3, 2022
• Results First Posted: May 23, 2017

Record last verified: 2022-07

Locations

US (1)