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Measuring Cerebral Blood Flow Using Pseudo-continuous Arterial Spin Labeling Perfusion Magnetic Resonance Imaging

Primary Purpose

Traumatic Brain Injury, Multiple Sclerosis, Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnetic Resonance Imaging
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Magentic Resonance Imaging

    Arm Description

    magnetic Resonance Imaging.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 6, 2016
    Last Updated
    April 9, 2019
    Sponsor
    Loma Linda University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02767609
    Brief Title
    Measuring Cerebral Blood Flow Using Pseudo-continuous Arterial Spin Labeling Perfusion Magnetic Resonance Imaging
    Official Title
    Measuring Cerebral Blood Flow Using Pseudo-continuous Arterial Spin Labeling Perfusion Magnetic Resonance Imaging
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    March 3, 2017 (Actual)
    Study Completion Date
    March 3, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Loma Linda University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traumatic Brain Injury, Multiple Sclerosis, Alzheimer's Disease, Tumor

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Magentic Resonance Imaging
    Arm Type
    Experimental
    Arm Description
    magnetic Resonance Imaging.
    Intervention Type
    Device
    Intervention Name(s)
    Magnetic Resonance Imaging
    Intervention Description
    All participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence.
    Primary Outcome Measure Information:
    Title
    Regional Cerebral Blood Flow Values of the Brain Measured Using Pseudo-continuous Arterial Spin Labeling (pCASL) MRI.
    Description
    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.
    Time Frame
    single encounter

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brenda Bartnik Olson, PhD
    Organizational Affiliation
    Loma Linda University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Measuring Cerebral Blood Flow Using Pseudo-continuous Arterial Spin Labeling Perfusion Magnetic Resonance Imaging

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