- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02767609
Measuring Cerebral Blood Flow Using Pseudo-continuous Arterial Spin Labeling Perfusion Magnetic Resonance Imaging
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Electronic or metal implant that is not MRI safe, pregnancy or claustrophobia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Magentic Resonance Imaging
magnetic Resonance Imaging.
|
All participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
single encounter
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brenda Bartnik Olson, PhD, Loma Linda University Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Wounds and Injuries
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Dementia
- Tauopathies
- Multiple Sclerosis
- Brain Injuries
- Brain Injuries, Traumatic
- Alzheimer Disease
Other Study ID Numbers
- 5140083
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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