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New treatment option for CAROTID STENOSIS
Official title Plaque and Brain Inflammation in Symptomatic Carotid Stenosis: Role of the Ficolin-2
ClinicalTrials.gov ID: NCT05850247
What this study is testing
What is [18F]DPA-714 PET/MRI?
[18F]DPA-714 PET/MRI is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for carotid stenosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Carotid artery stenosis is observed in about 3% of ≥ 60 years subjects and accounts for around 10-20% of all ischemic strokes. Beyond the degree of stenosis, plaque composition affects the risk of ischemic stroke.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients 18 years or over,
- Signed written informed consent before any study specific intervention,
- Probable ipsilateral transient ischemic attack (TIA - which involve a focal speech/language, motor or visual deficit referable to the distribution of...
- Atherosclerotic carotid stenosis between 50% and 99% (NASCET method), as confirmed by one of the imaging examinations (among: Doppler ultrasound, MR...
- No other identified cause of TIA, ischemic stroke or retinal artery occlusion,
You likely can't join if
- Patients with inflammatory or autoimmune disease, hepatocellular insufficiency, acute or chronic infection, active malignancy, myocardial infarction...
- Patients with severe renal insufficiency (estimated GFR \< 30 ml/min at inclusion or known dialysis),
- Patients with contraindication to MRI (agitation, claustrophobia, pacemaker, metallic (ferromagnetic) body, a known allergy to gadolinium) according...
- Patients with modified Rankin score greater than 3,
- Patients currently enrolled in another clinical trial including investigational medicinal products,
- Female patient who is pregnant or lactating, or is of child-bearing and who did not agree to use highly effective methods of birth control throughout...
See the full eligibility criteria
- Patients 18 years or over,
- Signed written informed consent before any study specific intervention,
- Probable ipsilateral transient ischemic attack (TIA - which involve a focal speech/language, motor or visual deficit referable to the distribution of a carotid artery and lasting less than 48 hours from the onset) OR...
- Atherosclerotic carotid stenosis between 50% and 99% (NASCET method), as confirmed by one of the imaging examinations (among: Doppler ultrasound, MR angiography, CT angiography, catheter angiography) performed after...
- No other identified cause of TIA, ischemic stroke or retinal artery occlusion,
- Patients with inflammatory or autoimmune disease, hepatocellular insufficiency, acute or chronic infection, active malignancy, myocardial infarction or major surgery within the previous 30 days of index hospitalization...
- Patients with severe renal insufficiency (estimated GFR \< 30 ml/min at inclusion or known dialysis),
- Patients with contraindication to MRI (agitation, claustrophobia, pacemaker, metallic (ferromagnetic) body, a known allergy to gadolinium) according to the investigator's judgment,
- Patients with modified Rankin score greater than 3,
- Patients currently enrolled in another clinical trial including investigational medicinal products,
- Female patient who is pregnant or lactating, or is of child-bearing and who did not agree to use highly effective methods of birth control throughout the study,
- Patient without health coverage,
- Patient under legal protection
The study team makes the final eligibility decision.
Where it's taking place
- Bron, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bron, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.