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

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Conditions: Traumatic Brain Injury; Multiple Sclerosis; Alzheimer's Disease; Tumor
• Intervention: Device: Magnetic Resonance Imaging
• Enrollment: 1

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Magentic Resonance Imaging
Arm/Group Description	Magnetic Resonance Imaging. Magnetic Resonance Imaging: All participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence.
Period Title: Overall Study
Started	1
Completed	1
Not Completed	0

Baseline Characteristics

Arm/Group Title		Magentic Resonance Imaging
Arm/Group Description		Magnetic Resonance Imaging. Magnetic Resonance Imaging: All participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence.
Overall Number of Baseline Participants		1
Baseline Analysis Population Description		any person between age of 18-90
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	1 participants
		32 (0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants
	Female	1
	Male	0
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	1 participants
		1

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

control

Arm/Group Title	Magentic Resonance Imaging
Arm/Group Description:	Magnetic Resonance Imaging. Magnetic Resonance Imaging: All participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence.
Overall Number of Participants Analyzed	1
Mean (Standard Deviation); Unit of Measure: ml/100g/min
	35.4 (5.7)

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Magentic Resonance Imaging
Arm/Group Description	Magnetic Resonance Imaging. Magnetic Resonance Imaging: All participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence.
All-Cause Mortality
	Magentic Resonance Imaging
	Affected / at Risk (%)
Total	0/1 (0.00%)
Serious Adverse Events
	Magentic Resonance Imaging
	Affected / at Risk (%)
Total	0/1 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Magentic Resonance Imaging
	Affected / at Risk (%)
Total	0/1 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Brenda Bartnik Olson
• Organization: Loma Linda University medical Center
• Phone: 909-558-4000 ext 85216
• EMail: bbartnik@llu.edu

• Responsible Party: Brenda Bartnik Olson, PhD, Loma Linda University
• ClinicalTrials.gov Identifier: NCT02767609
• Other Study ID Numbers: 5140083
• First Submitted: May 6, 2016
• First Posted: May 10, 2016
• Results First Submitted: February 26, 2019
• Results First Posted: April 30, 2019
• Last Update Posted: April 30, 2019