Functional Magnetic Resonance ImagingPhase 1NCT01244282
A Study of Two Methodologies for Measuring Blood Flow in the Brain in Response to Non-Drug Stimuli (P08085/MK-0000-180)
A Phase 1 study testing fMRI with sensory stimulation in people with Functional Magnetic Resonance Imaging, run by Merck Sharp & Dohme LLC.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Functional Magnetic Resonance Imaging
- What is being tested?
- fMRI with sensory stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the detailed description
Study Design: Translational Medicine - Imaging Platform Development
- Conditions
- Functional Magnetic Resonance Imaging
- Being tested
- fMRI with sensory stimulation
- Keywords
- brain imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI with sensory stimulationProcedure or surgery
BOLD fMRI study with sensory stimulation followed by fMRI in the presence of increasing concentrations of ferumoxytol (Feraheme™)
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | fMRI studies with sensory stimulation in the presence of 0 mg, 250 mg, 350 mg, and 510 mg cumulative doses of ferumoxytol Receives: Procedure: fMRI with sensory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of the MRI percent signal change in response to sensory stimulation without administration of ferumoxytol (BOLD fMRI)
Measured: 45 minutes after initiation of imaging procedures
Magnitude of the MRI percent signal change in response to sensory stimulation following administration of the first dose of ferumoxytol (250 mg)
Measured: 55 minutes after initiation of imaging procedures
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)
Measured: 70 minutes after initiation of imaging procedures
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)
Measured: 85 minutes after initiation of imaging procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244282
- Sponsor's protocol ID
- P08085
- Status last verified
- Jun 2016
- First submitted
- 17 Nov 2010
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01244282
- Acronym / sponsor ID
- P08085
- Conditions
- Functional Magnetic Resonance Imaging
- Keywords
- brain imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Procedure: fMRI with sensory stimulationfMRI studies with sensory stimulation in the presence of 0 mg, 250 mg, 350 mg, and 510 mg cumulative doses of ferumoxytol |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI with sensory stimulationBOLD fMRI study with sensory stimulation followed by fMRI in the presence of increasing concentrations of ferumoxytol (Feraheme™) | Procedure or surgery | All Participants |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing fMRI with sensory stimulation in people with Functional Magnetic Resonance Imaging, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2016.