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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02767609
Recruitment Status : Completed
First Posted : May 10, 2016
Results First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Information provided by (Responsible Party):
Brenda Bartnik Olson, PhD, Loma Linda University

Tracking Information
First Submitted Date  ICMJE May 6, 2016
First Posted Date  ICMJE May 10, 2016
Results First Submitted Date  ICMJE February 26, 2019
Results First Posted Date  ICMJE April 30, 2019
Last Update Posted Date April 30, 2019
Study Start Date  ICMJE May 2014
Actual Primary Completion Date March 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2016)
Regional cerebral blood flow values of the brain measured using pseudo-continuous arterial spin labeling (pCASL) MRI. [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Measuring Cerebral Blood Flow Using Pseudo-continuous Arterial Spin Labeling Perfusion Magnetic Resonance Imaging
Official Title  ICMJE Measuring Cerebral Blood Flow Using Pseudo-continuous Arterial Spin Labeling Perfusion Magnetic Resonance Imaging
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Traumatic Brain Injury
  • Multiple Sclerosis
  • Alzheimer's Disease
  • Tumor
Intervention  ICMJE Device: Magnetic Resonance Imaging
All participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence.
Study Arms  ICMJE Experimental: Magentic Resonance Imaging
magnetic Resonance Imaging.
Intervention: Device: Magnetic Resonance Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2016)
Actual Study Completion Date  ICMJE March 3, 2017
Actual Primary Completion Date March 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02767609
Other Study ID Numbers  ICMJE 5140083
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Brenda Bartnik Olson, PhD, Loma Linda University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Loma Linda University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brenda Bartnik Olson, PhD Loma Linda University Medical Center
PRS Account Loma Linda University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP