Brain InjuriesNCT02702635
Measuring Blood Flow Characteristics Using Dynamic Contrast Enhanced Magnetic Resonance Imaging
A study testing DCE MRI of the brain in people with Brain Injuries and Cerebrovascular Disorders, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Cerebrovascular Disorders
- What is being tested?
- DCE MRI of the brain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2015to 26 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
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.
Read the 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.
- Conditions
- Brain Injuries, Cerebrovascular Disorders
- Being tested
- DCE MRI of the brain
- Medical subject headings
- Brain Injuries, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCE MRI of the brainProcedure or surgery
An MRI of the brain including a DCE sequence
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | Experimental | All recruited subjects Receives: Procedure: DCE MRI of the brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Ktrans values and Omega3 levels
Measured: 2 years
Correlation between Ktrans values and neurocognitive testing
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study start15 Sep 2015
- Primary completion26 May 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Barnes, PhD, Principal investigator, Loma Linda University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702635
- Sponsor's protocol ID
- 5150234
- Status last verified
- Jun 2021
- First submitted
- 3 Mar 2016
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Blood Flow Characteristics Using Dynamic Contrast Enhanced Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02702635
- Acronym / sponsor ID
- 5150234
- Conditions
- Brain Injuries, Cerebrovascular Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects | Experimental | Procedure: DCE MRI of the brainAll recruited subjects |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCE MRI of the brainAn MRI of the brain including a DCE sequence | Procedure or surgery | All Subjects |
Primary outcome
Correlation between Ktrans values and Omega3 levels
Time frame: 2 years
Correlation between Ktrans values and neurocognitive testing
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Barnes, PhD principal investigator
Loma Linda University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DCE MRI of the brain in people with Brain Injuries and Cerebrovascular Disorders, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Ktrans values and Omega3 levels (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.