A Phase 2 interventional study of [18F]DPA-714 PET/MRI in CAROTID STENOSIS, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Hospices Civils de Lyon · Phase 2, Interventional, and Treatment
Among 28 studies in Carotid Stenosis with a site in France — 2 open to participants now, 3 under way, none of them phase 3. Carotid Stenosis · France.
Among the 28 studies in Carotid Stenosis with a site in France, this one is the 13th largest by planned enrollment of the 16 interventional ones that give a count, is the only one that started in 2024, is one of 2 in phase 2, and was the 26th registered.
364 studies on the registry are indexed under Carotid Stenosis; 85 are open to participants now.
Browse Carotid Stenosis studies →2 of the 28 studies in Carotid Stenosis with a site in France are open now. Recruiting first, the newest first:
Hospices Civils de Lyon · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 60 Carotid Stenosis studies recruiting now, 38 (63%) set no upper age limit and none (0%) stop at 75 or younger; 4 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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28 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 1 started in 2024.
This study's planned enrollment of 20 is below the median of 103 across 189 interventional studies indexed under Carotid Stenosis.
Median enrollment 82 across the 16 interventional studies, 202 across the 12 observational. Of the 22 that completed or were terminated, 1 (5%) have results posted.
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7 of 28 have an industry lead sponsor. The 10 most frequent:
Hospices Civils de Lyon is the lead sponsor of 1,867 studies on the registry; 448 are open to participants now.
Hospices Civils de Lyon has 4 studies filed under Carotid Stenosis — fewer than ten, so there is no comparison to draw.
2 of the studies in Carotid Stenosis with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05850247Hospices Civils de LyonPlaque and Brain Inflammation in Symptomatic Carotid Stenosis: Role of the Ficolin-2 | 2026-12-31 |
| NCT02748941Hospices Civils de LyonCarotid Atherosclerosis : Innovative Imaging Biomarkers. Study Case-control | 2027-02-12 |
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Among the 28 studies in Carotid Stenosis with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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. Identification of patients with vulnerable plaques at higher risk of stroke who might benefit from carotid revascularization is crucial.
A growing body of evidence suggests that the lectin pathway of the complement system, and especially the ficolin-2, is involved in atherosclerosis. It has been hypothesized that circulating levels of ficolin-2 increase during chronic inflammatory conditions (i.e. growing atherosclerotic plaque) whereas they fall during sub-acute or acute inflammatory conditions (i.e. plaque rupture and acute ischemic stroke) because of consumption (binding to targets). Therefore, ficolin-2 has been proposed as a biomarker informing on the specific state of the plaque. However, in acute ischemic stroke due to carotid stenosis, both plaque rupture and stroke injury contribute to lectin pathway activation, thus affecting circulating levels of ficolin-2. Until now, the relative contribution of plaque and brain inflammation on circulating levels of ficolin-2 has not been documented.
In the present study the investigators aim to assess the association between circulating levels of ficolin-2 and carotid and brain inflammation on [18F]DPA-714 positron emission tomography (PET)/MRI in patients with transient ischemic attack or acute ischemic stroke due to carotid stenosis. For that purpose, the investigators intend to include 30 patients with transient ischemic attack or acute ischemic stroke due to ≥ 50%. carotid stenosis. Each patient will have a measure of plasmatic level of ficolin-2 as well a [18F]DPA-714 PET/MRI to quantify the fixation of the radiotracer on carotid and brain.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: [18F]DPA-714 PET/MRI
To assess the association between plasma ficolin-2 levels and plaque and brain inflammation assessed by \[18F\]DPA-714 PET/MRI in patients managed for transient ischaemic attack or ischaemic stroke related to carotid stenosis. PET/MRI of the brain and carotid plaque with \[18F\]DPA-714 and gadolinium infusion will be performed at day 5.
Correlation between: - Plasma levels of ficolin-2 at day 5 in ng/ml, - Metabolic data on [18F]DPA-714 PET/MRI
To assess the association between circulating levels of ficolin-2 and carotid and brain inflammation on \[18F\]DPA-714 PET/MRI in patients with transient ischemic attack or acute ischemic stroke due to carotid stenosis
Time frame: day 5
Correlation between plasma levels of ficolin-2 at day 5 in ng/mL with morphological data of the brain and carotid plaque assessed by MRI
To assess if plasma levels of ficolin-2 in patients with TIA or acute ischemic stroke due to carotid stenosis correlate with: 1. morphological data: * of the plaque: presence of intraplaque hemorrhage, lipid-rich necrotic core, thinning/rupture of the fibrous cap on carotid plaque MRI * of the brain: infarct size, presence of hemorrhagic transformation, blood-brain barrier leakage
Time frame: day 5
Correlation between plasma levels of ficolin-2 at day 5 in ng/mL with morphological data of the brain and carotid plaque assessed by MRI
To assess if plasma levels of ficolin-2 in patients with TIA or acute ischemic stroke due to carotid stenosis correlate with: - histological data of the retrieved plaque: hemorrhagic content, lipid core, cholesterol cleft areas, ratio between thickness of tunica media and total thickness of tunica, rupture, intraplaque deposition of ficolin-2, macrophages and neutrophils infiltration
Time frame: day 15
Started Feb 2024 (actual). Primary completion is estimated for Dec 2026, 34 months after the start.
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