Measuring Blood Flow Characteristics Using Dynamic Contrast Enhanced Magnetic Resonance Imaging
1 other identifier
interventional
53
1 country
1
Brief Summary
Dynamic contrast-enhanced (DCE) MRI gives quantitative and semi-quantitative information about the integrity of the vascular system and can be used to quantify blood-brain barrier (BBB) integrity. The BBB plays a pathophysiological role in diabetes, cognitive disorders such as mild cognitive impairment, Alzheimer's disease, multiple sclerosis, and chronic traumatic encephalopathy. Although dysfunctional, changes in BBB integrity for these conditions are thought to be subtle and close to intact values. Recent studies have shown it is possible measure small changes in the BBB integrity as an early sign of disease using DCE MRI. The objective of this study is to apply an optimized DCE imaging protocol and novel image post-processing to obtain new information about the BBB integrity in aging. These techniques show promise for both improving clinical diagnosis, and elucidated the physiology or various disease processes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2015
CompletedFirst Submitted
Initial submission to the registry
March 3, 2016
CompletedFirst Posted
Study publicly available on registry
March 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2021
CompletedJuly 1, 2021
June 1, 2021
5.7 years
March 3, 2016
June 29, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Correlation between Ktrans values and Omega3 levels
2 years
Correlation between Ktrans values and neurocognitive testing
2 years
Study Arms (1)
All Subjects
EXPERIMENTALAll recruited subjects
Interventions
Eligibility Criteria
You may qualify if:
- Any person between the ages of 0-100 years, who is undergoing routine magnetic resonance imaging (MRI) with contrast at LLUMC.
- Any person between the ages of 18-100 years, who agrees to undergo routine magnetic resonance imaging (MRI) with contrast at LLUMC.
You may not qualify if:
- Electronic or metal implant that is not MRI safe, pregnancy or claustrophobia
- Not eligible for contrast agent injection (reduced renal function, GFR \< 30 mL/min)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Barnes, PhD
Loma Linda University Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2016
First Posted
March 8, 2016
Study Start
September 15, 2015
Primary Completion
May 26, 2021
Study Completion
May 26, 2021
Last Updated
July 1, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share