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Trial record 10 of 155 for:    (Dementia pugilistica OR chronic traumatic encephalopathy)

Measuring Blood Flow Characteristics Using Dynamic Contrast Enhanced Magnetic Resonance Imaging

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ClinicalTrials.gov Identifier: NCT02702635
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Samuel Barnes, Loma Linda University

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 trauma. These techniques show promise for both improving clinical diagnosis, and elucidated the physiology or various disease processes.

Condition or disease Intervention/treatment Phase
Brain Injuries Cerebrovascular Disorders Procedure: DCE MRI of the brain Not Applicable

Detailed Description:

Objectives The objective of this investigator-initiated study is to continue and extend this research by applying our optimized DCE imaging protocol (using the standard FDA approved DCE sequence) and our novel image post-processing to obtain new information about the BBB integrity in trauma .

Study Procedure Overview: Patient's at LLUMC with an existing order for a MRI study of the head with contrast will be asked if they would like to participate in the study to evaluate if an optimized DCE sequence can provide more information about their disease.

Health controls will be asked if they would like to participate in the study in order to evaluate if the optimized DCE sequence can provide useful information about various CNS diseases.

Imaging: Following consent, subjects will be imaged at LLUMC using the 3T MRI scanner (Siemens Medical Solutions, Malvern, PA) after MRI safety screening questionnaire is complete. Subjects will be asked to lie on or be positioned on their backs in the MRI scanner. The coil will be placed around their head and the subject will be provided with headphones and/or earplugs during the scan. Imaging will consist of the diagnostic MR protocol requested by the ordering physician and the addition of the standard FDA approved DCE sequence.

Data Collection and Analysis The collected DCE data may be processed using standard FDA approved DCE software (which the department already owns and uses clinically), used for clinical decision making purposes, and added to the patients record. The data will also be processed using specialized research software, this processing will not be used for diagnostic or clinical decision making purposes, and will not be added to the patients record. Ktrans values will be measured using region of interest analysis from the processed DCE data to determine if there are differences between the pathology of interest and healthy controls.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Measuring Blood Flow Characteristics Using Dynamic Contrast Enhanced Magnetic Resonance Imaging
Actual Study Start Date : September 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Experimental: All Subjects
All recruited subjects
Procedure: DCE MRI of the brain
An MRI of the brain including a DCE sequence




Primary Outcome Measures :
  1. Differences in Ktrans values between patients and controls [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any person between the ages of 0-100 years, who is undergoing routine magnetic resonance imaging (MRI) with contrast at LLUMC.

Or

• Any person between the ages of 18-100 years, who agrees to undergo routine magnetic resonance imaging (MRI) with contrast at LLUMC.

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702635


Contacts
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Contact: Samuel Barnes, PhD 909-558-7394 sabarnes@llu.edu

Locations
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United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Samuel Barnes, PhD    909-558-7394    sabarnes@llu.edu   
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Samuel Barnes, PhD Loma Linda University Health

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Responsible Party: Samuel Barnes, Assistant Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT02702635     History of Changes
Other Study ID Numbers: 5150234
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Brain Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases