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MR, Histologic And EM Imaging Of Intravenous Ferumoxytol In Central Nervous System (CNS) Inflammation

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Oregon Health and Science University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Edward Neuwelt, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00659776
First received: April 10, 2008
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to address safety and efficiency of a new iron particle contrast agent, ferumoxytol. This product may be more useful in viewing the vessels of the brain and areas in the brain on magnetic resonance imaging (MRI), or magnetic resonance angiography (MRA), than the standard substance, gadolinium, injected during MRI and MRA.

Other ways in which ferumoxytol may help include the following:

  1. Ferumoxytol may provide the ability to better see inflammatory lesions on magnetic resonance imaging (MRI) scans
  2. Ferumoxytol may be useful in its ability to cross blood vessels into inflammatory processes, and
  3. Ferumoxytol, because of its size and ability to get into the area next to your inflammatory lesion and could assist in the treatment of inflammatory lesions association with cardiac surgery or CNS vascular surgery.

Condition Intervention Phase
Nervous System Diseases
Diagnostic Imaging
Drug: Ferumoxytol
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Multi-Disciplinary Study: MR, Histologic And EM Imaging Of Intravenous Superparamagnetic Crystalline Particles (Ferumoxytol) In CNS Inflammation

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • To assess the safety of ferumoxytol. [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare ferumoxytol MR with the "gold standard" gadolinium enhanced MR in adults with CNS inflammatory or demyelinating brain disease (multiple sclerosis) or related diseases such a as ADEM. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • To compare ferumoxytol MR with the "gold standard" gadolinium enhanced MR in adults with ischemic processes, stroke, or undergoing CNS vascular surgery (carotid stenting or carotid endarterectomy). [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • To identify inflammatory and embolic lesions in the brains of patients undergoing cardiac surgery with and without cardiopulmonary bypass utilizing ferumoxytol enhanced MRI. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • To evaluate the use of ferumoxytol MRA to image the vascular bed of CNS inflammatory and ischemic lesions. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • To evaluate the utility of ferumoxytol to differentiate between inflammatory and neoplastic lesions. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • To localize ferumoxytol particles with histology and electron microscopy in biopsy samples in which the diagnosis is unclear and biopsy is needed to exclude lymphoma or other alternative diagnosis and compare with imaging results. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Subjects with MS or any other inflammatory process
Drug: Ferumoxytol
Ferumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials)
Other Name: Feraheme
Active Comparator: 2
Subjects with stroke
Drug: Ferumoxytol
Ferumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials)
Other Name: Feraheme
Active Comparator: 3
Subjects receive ferumoxytol before cardiac surgery or CNS vascular surgery
Drug: Ferumoxytol
Ferumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials)
Other Name: Feraheme
Active Comparator: 4
Subjects receive ferumoxytol after cardiac surgery or CNS vascular surgery
Drug: Ferumoxytol
Ferumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials)
Other Name: Feraheme

Detailed Description:

Subjects are recruited as patients in one of the neurology, neurosurgery, neuro-oncology, Multiple Sclerosis Clinic or cardiothoracic surgery clinics at OHSU. Eligible subjects will be enrolled in different groups based on their disease (MS, cardiac surgery or CNS vascular surgery, stroke). Subsequently a MRI and MRA of the brain using the standard contrast agent (Gadolinium) will be obtained; this study will be compared with the ferumoxytol-contrasted MRA and MRIs performed the next day(s).

Visit 1: the subjects are enrolled and distributed in their corresponding group; also basic laboratory studies are obtained as well as a Gadolinium contrasted MRI and MRA of the brain.

For Groups 1 and 2 (MS and Stroke):

Visit 2: Ferumoxytol will be injected as an i.v. bolus. The total dose over 2 hours will not exceed 510mg, and can be divided into multiple smaller doses such as 1 mg Fe/kg to optimize MRA imaging and may be diluted up to 4 fold in normal saline to reduce T2* effects in the MR angiography.

Visit 3: 24 hours after the second visit an MRI with the standard contrast agent will be done.

Last visit: 1 month after Ferumoxytol administration, the subject will be reassessed with physical and laboratory exams.

For Groups 3 and 4 (Cardiac surgery or CNS vascular surgery):

After the screening visit (Visit 1) and baseline MRI and MRA you will be randomly assigned to one of two groups. These groups are very similar but there are slight differences in the schedule of events.

  • Group 3a and 4a: ferumoxytol infusion (Visit 2) before surgery
  • Group 3b and 4b: ferumoxytol infusion (Visit 2) after surgery

Visit 2: Ferumoxytol will be injected as an i.v. bolus. The total dose over 2 hours will not exceed 510mg, and can be divided into multiple smaller doses such as 1 mg Fe/kg to optimize MRA imaging and may be diluted up to 4 fold in normal saline to reduce T2* effects in the MR angiography.

Visit 3: 24-72 hours after the second visit an MRI with the standard contrast agent will be done.

Last visit: 1 month after Ferumoxytol administration, the subject will be reassessed with physical and laboratory exams.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have a clinical, radiological or established histological diagnosis of multiple sclerosis, stroke, or be requiring cardiac or CNS vascular surgery. Subjects with a CNS inflammatory lesion that is suspicious for neoplasm or radiation induced inflammation (vasculitis) will also be included (group 1a). McDonald's criteria will be used for the diagnosis of multiple sclerosis.
  • Subjects must be 18 years or older
  • Subjects will be followed for at least 1 month after the infusion of ferumoxytol.
  • All subjects or their authorized representative must sign a written informed consent and give HIPAA authorization in accordance with institutional guidelines.
  • Female subjects of child-bearing potential must be postmenopausal, surgically sterile, or using a reliable form of contraception for at least a month. These criteria can be waved at the discretion of the investigator if the one-month wait required is not in the best interest of the patient.
  • Karnofsky must be 30% or greater

Exclusion Criteria:

  • Subjects with clinically significant signs of uncal herniation
  • 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 Gd contrast material.
  • Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations
  • Subjects with known hepatic insufficiency or cirrhosis
  • Subjects with known or suspected iron overload
  • HIV-positive subjects on combination anti-retroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol
  • Pregnant or lactating women are excluded from this study because of possible risk to the fetus or infant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659776

Contacts
Contact: Edward A Neuwelt, MD 503-494-5626 neuwelte@ohsu.edu
Contact: Cindy A Lacy, BSN 503-494-5626 lacyc@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Edward A Neuwelt, MD    503-494-5626    neuwelte@ohsu.edu   
Principal Investigator: Edward A Neuwelt, MD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Edward A Neuwelt, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Edward Neuwelt, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00659776     History of Changes
Other Study ID Numbers: OHSU-1562, 5R01NS034608
Study First Received: April 10, 2008
Last Updated: November 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:
ferumoxytol

Additional relevant MeSH terms:
Inflammation
Nervous System Diseases
Pathologic Processes
Ferumoxytol
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014