NCT01244282

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Male
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Study Design: Translational Medicine - Imaging Platform Development

Conditions

• Functional Magnetic Resonance Imaging

Interventions

Type	Name	Description
PROCEDURE	fMRI with sensory stimulation	BOLD fMRI study with sensory stimulation followed by fMRI in the presence of increasing concentrations of ferumoxytol (Feraheme™)

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-02-01
• Completion: 2011-04-01
• First posted: 2010-11-19
• Last updated: 2016-06-10