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[18F]DPA-714 Imaging for Carotid Artery Disease
Phase 1
Recruiting
Led By Jonathan McConathy, MD,PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cohort 1 - Critical Asymptomatic Carotid Stenosis Group: Diagnosis of Asymptomatic Carotid Artery Disease (aCAD) with >70% stenosis or peak systolic velocity on DUS ≥ 230 cm/s plus CTA or MRA confirmation
Cohort 2 - Non-Critical Asymptomatic Carotid Stenosis Group: No planned revascularization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-study to 48 hours post pet imaging.
Awards & highlights
Study Summary
This trial will examine if there is a difference in neuroinflammation between those with high and low grade asymptomatic carotid artery stenosis using the [18F]DPA-714 PET tracer.
Who is the study for?
This trial is for adults with asymptomatic carotid artery disease, either with over 70% stenosis or less than 40%, depending on the group. Participants must be fluent in English, have at least an 8th-grade education, and show high affinity binding for TSPO ligands. Pregnant women, individuals with major depression, dementia, previous strokes or head injuries are excluded.Check my eligibility
What is being tested?
[18F]DPA-714 PET tracer is being tested to measure neuroinflammation in patients with different severities of asymptomatic carotid artery disease. The study involves comparing brain scans from two groups: one with critical stenosis and another with non-critical stenosis.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include reactions to the PET tracer such as discomfort at injection site or allergic reactions; however these are generally rare.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a severe narrowing in my carotid artery but no symptoms.
Select...
I have a narrowed carotid artery but no plans for surgery to fix it.
Select...
I am in the non-critical, asymptomatic carotid stenosis group with a specific genetic marker.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-study to 48 hours post pet imaging.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-study to 48 hours post pet imaging.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total volume distribution of the regional time-activity curves from the TSPO- PET Data.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2 - Controls-Non-Critical Asymptomatic Carotid Stenosis GroupExperimental Treatment1 Intervention
<40% carotid stenosis No planned revascularization
Group II: Cohort 1 - Critical Asymptomatic Carotid Stenosis GroupExperimental Treatment1 Intervention
Critical Stenosis Group: Diagnosis of Asymptomatic Carotid Artery Disease (aCAD) with >70% stenosis or peak systolic velocity on duplex ultrasound (DUS) ≥ 230 cm/s plus computed tomography angiography (CTA) or magnetic resonance angiography (MRA) confirmation.
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,334 Total Patients Enrolled
Jonathan McConathy, MD,PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My genetic test shows low or mixed-affinity for TSPO ligands.I have had a procedure to improve blood flow to my heart.I have had a stroke before.I have a genetic marker linked to better outcomes in carotid stenosis treatment.I am scheduled for a procedure to open my narrowed neck artery in more than 14 days.I am 18 or older with non-critical, symptom-free carotid artery narrowing.I have a severe narrowing in my carotid artery but no symptoms.My carotid artery narrowing is less than 40%.I have a narrowed carotid artery but no plans for surgery to fix it.I have been diagnosed with major depression.You have been diagnosed with dementia in the past.You cannot have an MRI for medical reasons.Your blood hemoglobin level is very low, less than 8 mg/dL.You have had an MRI scan that showed a significant health problem.You had a serious head injury with loss of consciousness for more than 30 minutes or had a seizure at the time of the injury.I am over 18 and have critical but symptom-free narrowing of my carotid artery.I am in the non-critical, asymptomatic carotid stenosis group with a specific genetic marker.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2 - Controls-Non-Critical Asymptomatic Carotid Stenosis Group
- Group 2: Cohort 1 - Critical Asymptomatic Carotid Stenosis Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies in this research endeavor?
"Affirmative. According to the information hosted on clinicaltrials.gov, this medical trial has been open since December 1st 2022 and is actively seeking candidates. 20 participants are being recruited from a single centre."
Answered by AI
How many individuals have been accepted into the clinical trial thus far?
"Affirmative. The information on clinicaltrials.gov declares that this medical trial is actively recruiting patients, having been posted in December of 2022 and modified more recently in August of the same year. This endeavor requires 20 individuals to be enlisted from one location."
Answered by AI
Has the Food and Drug Administration been consulted about [18F]DPA-714?
"The safety profile of [18F]DPA-714 has been assigned a rating of 1 due to the limited research available and the fact that it is in Phase 1 clinical trials."
Answered by AI
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