CompletedNot Applicable

Carotid Plaque Assessment Using 18Fluorine (18F) -Sodium Fluoride Positron Emission Tomography (PET) /MR

France15 participantsStarted 2016-01-15

Plain-language summary

Carotid plaque can lead to ischemic stroke. Treatment of asymptomatic carotid plaque, based on degree stenosis, is still controversial. Beyond the degree of stenosis, the composition of the plaque could reflect the vulnerability and the risk of ipsilateral ischemic stroke. Identification of new predictive factor of ipsilateral ischemic stroke in patients with carotid plaque could help to screen high risk patients and to guide the treatment. The aim of the study is to assess 18F-sodium fluoride uptake among carotid plaque in recently symptomatic and asymptomatic patients. Investigators conduct a pilot case-control study. Twelve patients (6 recently symptomatic and 6 asymptomatic) with carotid stenosis (≥50% NASCET) will have a 18F-sodium fluoride PET/MR. Standardized uptake value (SUV) and tissue-to-background ratio (TBR) will be measured among carotid plaques.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria symptomatic patients: * age\>18 * Carotid plaque ≥ 50% symptomatic (ischemic stroke on CT or MR) during the last 15 days or asymptomatic * ability to give informed consent * affiliation to social security Exclusion Criteria: * Modified Rankin score ˃ 3 * Contraindication to MRI * Renal failure (creatinine clearance by cockcroft ˂ 50 ml / min) * Pregnancy / Breastfeeding * Hypersensitivity to the active substance or excipients

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%

Timeframe: during the last 15 days in symptomatic patients

Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%

Timeframe: at day 0 in asymptomatic patients

Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%

Timeframe: at day 0 in asymptomatic patients

Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%

Timeframe: during the last 15 days in symptomatic patients

Trial details

NCT IDNCT02726984

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12-12

View on ClinicalTrials.gov More Carotid Artery Plaque trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%

Timeframe: during the last 15 days in symptomatic patients

Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%

Timeframe: at day 0 in asymptomatic patients

Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%

Timeframe: at day 0 in asymptomatic patients

Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%

Timeframe: during the last 15 days in symptomatic patients