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
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries Cerebrovascular Disorders||Procedure: DCE MRI of the brain||Not Applicable|
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.
|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|
Experimental: All Subjects
All recruited subjects
Procedure: DCE MRI of the brain
An MRI of the brain including a DCE sequence
- Differences in Ktrans values between patients and controls [ Time Frame: 2 years ]
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
|Contact: Samuel Barnes, PhDfirstname.lastname@example.org|
|United States, California|
|Loma Linda University Medical Center||Recruiting|
|Loma Linda, California, United States, 92354|
|Contact: Samuel Barnes, PhD 909-558-7394 email@example.com|
|Principal Investigator:||Samuel Barnes, PhD||Loma Linda University Health|