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A Study of Two Methodologies for Measuring Blood Flow in the Brain in Response to Non-Drug Stimuli (P08085/MK-0000-180)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01244282
First received: November 17, 2010
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

This study will identify a dose of ferumoxytol that can reliably detect changes in blood flow/volume in response to non-drug stimuli. The study will determine whether signal detection for functional magnetic resonance imaging (fMRI) using ferumoxytol is better than that for blood oxygen level-dependent (BOLD) fMRI in response to sensory stimulation. The following procedures will be conducted in each of two study periods: arterial spin labeling (ASL) imaging study with increasing exposure to carbon dioxide (CO2); BOLD fMRI study with sensory stimulation; MRI studies with sensory stimulation in the presence of increasing doses of ferumoxytol; MRI study with increasing exposure to CO2 in the presence of ferumoxytol. There will be a 3-week interval between the two study periods. The study will enroll 8 subjects, but an additional 4 subjects are permitted to enroll to preserve study power.


Condition Intervention Phase
Functional Magnetic Resonance Imaging
Procedure: fMRI with sensory stimulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Pilot Clinical Trial to Study Arterial Spin Labeling and USPIO-enhanced MRI Methodologies for Measuring Hemodynamic Responses to Non-Drug Stimuli in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Magnitude of the MRI percent signal change in response to sensory stimulation without administration of ferumoxytol (BOLD fMRI) [ Time Frame: 45 minutes after initiation of imaging procedures ] [ Designated as safety issue: No ]
  • Magnitude of the MRI percent signal change in response to sensory stimulation following administration of the first dose of ferumoxytol (250 mg) [ Time Frame: 55 minutes after initiation of imaging procedures ] [ Designated as safety issue: No ]
  • Magnitude of the MRI percent signal change in response to sensory stimulation following administration of the second dose of ferumoxytol (100 mg, total cumulative dose of 350 mg) [ Time Frame: 70 minutes after initiation of imaging procedures ] [ Designated as safety issue: No ]
  • Magnitude of the MRI percent signal change in response to sensory stimulation following administration of the third dose of ferumoxytol (180 mg, total cumulative dose of 510 mg) [ Time Frame: 85 minutes after initiation of imaging procedures ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: November 2010
Study Completion Date: April 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All Participants
fMRI studies with sensory stimulation in the presence of 0 mg, 250 mg, 350 mg, and 510 mg cumulative doses of ferumoxytol
Procedure: fMRI with sensory stimulation
BOLD fMRI study with sensory stimulation followed by fMRI in the presence of increasing concentrations of ferumoxytol (Feraheme™)

Detailed Description:

Study Design: Translational Medicine - Imaging Platform Development

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant weighs approximately 55-75 kg and has a Body Mass Index (BMI) of 18-25 kg/m^2
  • Participant is in good health
  • Participant is a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 6 months

Exclusion Criteria:

  • Participant has a contraindication to MRI including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, or any other MRI-incompatible metal implants that cannot be safely removed
  • Participant has a condition that would limit his ability to complete MRI procedures, such as claustrophobia or chronic back pain
  • Participant plans to undergo MRI studies in the 3 months following the post-study visit
  • Participant has a history of hemochromatosis or other conditions of iron overload or disease of iron metabolism
  • Participant has a known sensitivity to ferumoxytol or iron-containing products or has a history of severe allergies, anaphylactic reaction, or intolerance to drugs and/or foods
  • Participant has a history of stroke, chronic seizures, or major neurological disorder
  • Participant is unable to refrain from the use of any medication, including prescription and non-prescription drugs or herbal remedies from approximately 2 weeks prior to the first dose of ferumoxytol until the post-study visit
  • Participant has a history of significant head injury/trauma with loss of consciousness lasting for 15 minutes and one or more of the following: a) recurring seizures resulting from head injury; b) persistent neurological or cognitive sequelae of the injury; c) cognitive rehabilitation following the injury
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01244282     History of Changes
Other Study ID Numbers: P08085
Study First Received: November 17, 2010
Last Updated: May 30, 2014
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Merck Sharp & Dohme Corp.:
brain imaging

ClinicalTrials.gov processed this record on November 25, 2014