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

• ClinicalTrials.gov Identifier: NCT02767609
• Recruitment Status: Completed
• First Posted: May 10, 2016
• Results First Posted: April 30, 2019
• Last Update Posted: April 30, 2019
• Sponsor: Loma Linda University
• Information provided by (Responsible Party): Brenda Bartnik Olson, PhD, Loma Linda University

Tracking Information

• First Submitted Date: May 6, 2016
• First Posted Date: May 10, 2016
• Results First Submitted Date: February 26, 2019
• Results First Posted Date: April 30, 2019
• Last Update Posted Date: April 30, 2019
• Study Start Date: May 2014
• Actual Primary Completion Date: March 3, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science

Condition

• Traumatic Brain Injury
• Multiple Sclerosis
• Alzheimer's Disease
• Tumor

Intervention

Device: Magnetic Resonance Imaging

All participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence.

Study Arms

Experimental: Magentic Resonance Imaging

magnetic Resonance Imaging.

Intervention: Device: Magnetic Resonance Imaging

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 13, 2017): 1
• Original Estimated Enrollment (submitted: May 9, 2016): 350
• Actual Study Completion Date: March 3, 2017
• Actual Primary Completion Date: March 3, 2017 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02767609
• Other Study ID Numbers: 5140083
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Brenda Bartnik Olson, PhD, Loma Linda University
• Original Responsible Party: Same as current
• Current Study Sponsor: Loma Linda University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Brenda Bartnik Olson, PhD; Loma Linda University Medical Center

• PRS Account: Loma Linda University
• Verification Date: April 2019