- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02702635
Measuring Blood Flow Characteristics Using Dynamic Contrast Enhanced Magnetic Resonance Imaging
Study Overview
Status
Conditions
Intervention / Treatment
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 aging.
Study Procedure Overview: Subjects will be recruited either from patient's at LLUMC with an existing order for a MRI study of the head with contrast, or from an exisiting cohort at LLU that participated in a previous study.
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Loma Linda, California, United States, 92354
- Loma Linda University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: All Subjects
All recruited subjects
|
An MRI of the brain including a DCE sequence
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between Ktrans values and Omega3 levels
Time Frame: 2 years
|
2 years
|
Correlation between Ktrans values and neurocognitive testing
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samuel Barnes, PhD, Loma Linda University Health
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5150234
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebrovascular Disorders
-
Peking University Third HospitalBeijing HospitalCompletedCerebrovascular DiseasesChina
-
University Health Network, TorontoEisai Inc.CompletedDementia Associated With Cerebrovascular DiseaseCanada
-
Eisai Co., Ltd.CompletedA Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular DiseaseDementia Associated With Cerebrovascular DiseaseKorea, Republic of
-
First Affiliated Hospital of Harbin Medical UniversityRecruitingCerebrovascular Disease Small VesselChina
-
National Taiwan University HospitalNational Science Council, TaiwanUnknown
-
National Taiwan University HospitalNational Science Council, TaiwanUnknownCerebrovascular AccidentsTaiwan
-
Chinese PLA General HospitalNot yet recruitingCardiovascular and Cerebrovascular Diseases
-
University of Alabama at BirminghamCompleted
-
MyomoUnknownCerebrovascular AccidentsUnited States
-
Chang Gung Memorial HospitalNational Science Council, Taiwan; National Health Research Institutes, TaiwanCompleted
Clinical Trials on DCE MRI of the brain
-
University Hospital, MontpellierNovartisTerminatedParkinson's Disease | Multiple System Atrophy | Progressive Supranuclear Palsy | Vascular ParkinsonismFrance
-
University of MichiganNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedBrain TumorsUnited States
-
Universitaire Ziekenhuizen KU LeuvenRecruitingStatus Epilepticus | Positron-emission Tomography | Ictal-interictal Continuum | Perfusion Weighted MRI | Perfusion CTBelgium
-
NYU Langone HealthCompletedAlzheimer DiseaseUnited States
-
Stanford UniversityColumbia University; University of ManchesterRecruiting
-
Yonsei UniversityUnknownAdvanced Adult Hepatocellular CarcinomaKorea, Republic of
-
American College of Radiology Imaging NetworkNational Cancer Institute (NCI); Eastern Cooperative Oncology GroupUnknownBreast Cancer | BIRADS 3 | BIRADS 4 | BIRADS 5United States
-
NYU Langone HealthWithdrawn
-
University of UtahCompleted