Traumatic Brain InjuryNCT02767609
Measuring Cerebral Blood Flow Using Pseudo-continuous Arterial Spin Labeling Perfusion Magnetic Resonance Imaging
A study testing Magnetic Resonance Imaging in people with Traumatic Brain Injury and Multiple Sclerosis, run by Loma Linda University.
Trial summary
This study will test a new MRI sequence that measures cerebral blood flow (CBF). Because this technique for measuring CBF is new, there is little information on what the normal values for different regions of the brain should be. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Multiple Sclerosis, Alzheimer's Disease
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- May 2014to 3 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any person between the ages of 18-90 years, who is undergoing routine magnetic resonance imaging (MRI) of the head with or without contrast at Loma Linda University Medical Center.
- Must be eligible for MRI (no electronic or metal implants that are not MR compatible).
Who cannot join
- Electronic or metal implant that is not MRI safe, pregnancy or claustrophobia.
About this study
This study will test a new MRI sequence that measures cerebral blood flow (CBF). Because this technique for measuring CBF is new, there is little information on what the normal values for different regions of the brain should be. Information from the study will be used to establish normative CBF values for the brain, improving the reliable use of this technique for the diagnosis of brain injury or disease.
Read the detailed description
Cerebral blood flow (CBF) represents an important physiological parameter for the diagnosis and management of multiple brain disorders. The clinical need for CBF measurements is further complicated by the desire to have a non-invasive method with high temporal resolution that can measure CBF over a wide range of blood flows and in a wide range of patients. Numerous techniques are available to measure CBF. Nuclear medicine approaches, such as single positron emission computed tomography (SPECT) and positron emission tomography (PET) rely on radioisotopes which can be problematic in the pediatric population. In contrast, MRI-based methods are non-invasive and the CBF information can be obtained in conjunction with other MRI techniques (i.e. diffusion weighted imaging or spectroscopy) which allows for a combined longitudinal assessment of CBF, morphology, and metabolism, to provide a more complete understanding of the developing pathophysiological mechanisms.
Arterial spin labeling (ASL) perfusion imaging uses arterial blood water as an endogenous diffusible tracer where radiofrequency (RF) pulses magnetically label the moving spins in flowing blood without the use of a contrast agent. After a time delay allowing for the magnetically labeled blow to flow into the brain, "labeled" images are acquired. Separate control images are also acquired, without labeling and the difference between the two sets of imaged provides a measure of perfusion. Since gadolinium-based contrast agents are not required, the ASL perfusion technique is completely non-invasive. In addition, ASL techniques are insensitive to blood-brain barrier permeability changes, which can occur after strokes or with tumors.
Because gadolinium-based contrast is not used, the ASL technique has an inherently lower sensitivity than DSC-PWI. To date, there are a number of commercially available ASL techniques that differ in their labeling schemes, which has contributed to the difficulty in obtaining consistent results across different patient populations (pediatric, elderly, stroke, tumors). A number of recent reports using pseudo-continuous ASL (pCASL) have been published and show increased reliability across different patient populations. Moreover, a recent consensus statement published by the International Society of Magnetic Resonance in Medicine Perfusion Study Group recommends the use of pCASL labeling strategies for clinical applications.
The objectives of this study is to determine the accuracy and reliability of a newly developed pCASL sequence and post-processing software across multiple patient populations (neonate to elderly) and pathological processes.
- Conditions
- Traumatic Brain Injury, Multiple Sclerosis, Alzheimer's Disease, Tumor
- Being tested
- Magnetic Resonance Imaging
- Medical subject headings
- Brain Injuries, Traumatic, Multiple Sclerosis, Alzheimer Disease, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDevice
All participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence.
| Study group | Role | What they receive |
|---|---|---|
| Magentic Resonance Imaging | Experimental | magnetic Resonance Imaging. Receives: Device: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Cerebral Blood Flow Values of the Brain Measured Using Pseudo-continuous Arterial Spin Labeling (pCASL) MRI.
The relative cerebral blood flow (CBF) in frontal, parietal, occipital gray matter and white matter regions, basal ganglia, thalami, and cerebellum will be measured using region of interest analysis to determine institutional normative values for healthy subjects.
Measured: single encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startMay 2014
- Primary completion3 Mar 2017
- Study completion3 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brenda Bartnik Olson, PhD, Loma Linda University
- Investigators
- Brenda Bartnik Olson, PhD, Principal investigator, Loma Linda University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767609
- Sponsor's protocol ID
- 5140083
- Status last verified
- Apr 2019
- First submitted
- 6 May 2016
- Last updated
- 30 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Cerebral Blood Flow Using Pseudo-continuous Arterial Spin Labeling Perfusion Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02767609
- Acronym / sponsor ID
- 5140083
- Conditions
- Traumatic Brain Injury, Multiple Sclerosis, Alzheimer's Disease, Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 3 Mar 2017 (actual)
- Study completion
- 3 Mar 2017 (actual)
- First posted
- 10 May 2016 (estimated)
- Results
- Posted 30 Apr 2019
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 test a new MRI sequence that measures cerebral blood flow (CBF). Because this technique for measuring CBF is new, there is little information on what the normal values for different regions of the brain should be. Information from the study will be used to establish normative CBF values for the brain, improving the reliable use of this technique for the diagnosis of brain injury or disease.
Detailed description
Cerebral blood flow (CBF) represents an important physiological parameter for the diagnosis and management of multiple brain disorders. The clinical need for CBF measurements is further complicated by the desire to have a non-invasive method with high temporal resolution that can measure CBF over a wide range of blood flows and in a wide range of patients. Numerous techniques are available to measure CBF. Nuclear medicine approaches, such as single positron emission computed tomography (SPECT) and positron emission tomography (PET) rely on radioisotopes which can be problematic in the pediatric population. In contrast, MRI-based methods are non-invasive and the CBF information can be obtained in conjunction with other MRI techniques (i.e. diffusion weighted imaging or spectroscopy) which allows for a combined longitudinal assessment of CBF, morphology, and metabolism, to provide a more complete understanding of the developing pathophysiological mechanisms.
Arterial spin labeling (ASL) perfusion imaging uses arterial blood water as an endogenous diffusible tracer where radiofrequency (RF) pulses magnetically label the moving spins in flowing blood without the use of a contrast agent. After a time delay allowing for the magnetically labeled blow to flow into the brain, "labeled" images are acquired. Separate control images are also acquired, without labeling and the difference between the two sets of imaged provides a measure of perfusion. Since gadolinium-based contrast agents are not required, the ASL perfusion technique is completely non-invasive. In addition, ASL techniques are insensitive to blood-brain barrier permeability changes, which can occur after strokes or with tumors.
Because gadolinium-based contrast is not used, the ASL technique has an inherently lower sensitivity than DSC-PWI. To date, there are a number of commercially available ASL techniques that differ in their labeling schemes, which has contributed to the difficulty in obtaining consistent results across different patient populations (pediatric, elderly, stroke, tumors). A number of recent reports using pseudo-continuous ASL (pCASL) have been published and show increased reliability across different patient populations. Moreover, a recent consensus statement published by the International Society of Magnetic Resonance in Medicine Perfusion Study Group recommends the use of pCASL labeling strategies for clinical applications.
The objectives of this study is to determine the accuracy and reliability of a newly developed pCASL sequence and post-processing software across multiple patient populations (neonate to elderly) and pathological processes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magentic Resonance Imaging | Experimental | Device: Magnetic Resonance Imagingmagnetic Resonance Imaging. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any person between the ages of 18-90 years, who is undergoing routine magnetic resonance imaging (MRI) of the head with or without contrast at Loma Linda University Medical Center.
- Must be eligible for MRI (no electronic or metal implants that are not MR compatible).
Key exclusion criteria (1 listed)
- Electronic or metal implant that is not MRI safe, pregnancy or claustrophobia.
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 |
|---|---|---|
| Magnetic Resonance ImagingAll participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence. | Device | Magentic Resonance Imaging |
Primary outcome
Regional Cerebral Blood Flow Values of the Brain Measured Using Pseudo-continuous Arterial Spin Labeling (pCASL) MRI.
Time frame: single encounter
The relative cerebral blood flow (CBF) in frontal, parietal, occipital gray matter and white matter regions, basal ganglia, thalami, and cerebellum will be measured using region of interest analysis to determine institutional normative values for healthy subjects.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Brenda Bartnik Olson, PhD principal investigator
Loma Linda University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging in people with Traumatic Brain Injury and Multiple Sclerosis, run by Loma Linda University.
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 2 inclusion and 1 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 30 Apr 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Regional Cerebral Blood Flow Values of the Brain Measured Using Pseudo-continuous Arterial Spin Labeling (pCASL) MRI. (time frame: single encounter). 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 30 Apr 2019.