Carotid Artery PlaqueCARTISNCT02726984
Carotid Plaque Assessment Using 18Fluorine (18F) -Sodium Fluoride Positron Emission Tomography (PET) /MR
A study testing 18F-sodium fluoride PET/MR in people with Carotid Artery Plaque, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Plaque
- What is being tested?
- 18F-sodium fluoride PET/MR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2016to 12 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Symptomatic and Asymptomatic Carotid Plaques Using Hybrid Imaging 18F-sodium Fluoride PET/MR
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.
- Conditions
- Carotid Artery Plaque
- Being tested
- 18F-sodium fluoride PET/MR
- Keywords
- stroke, carotid plaque, 18F-sodium fluoride PET/MR
- Medical subject headings
- Carotid Stenosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-sodium fluoride PET/MRDrug
18F-sodium fluoride PET/MR combining 3Tesla (3T) MR and PET producing 127 slices of 2 mm on an axial field of view of 26 cm. 18F-sodium fluoride (2 à 4 megabecquerel/kilogram (MBq/kg)) will be injected 60 min before.
| Study group | Role | What they receive |
|---|---|---|
| case | Experimental | Patients with carotid plaque ≥ 50% symptomatic (ischemic stroke on CT or MR) during the last 15 days Receives: Drug: 18F-sodium fluoride PET/MR |
| control | Experimental | Patients with asymptomatic carotid plaque ≥ 50% Receives: Drug: 18F-sodium fluoride PET/MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%
Measured: during the last 15 days in symptomatic patients
Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%
Measured: at day 0 in asymptomatic patients
Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%
Measured: at day 0 in asymptomatic patients
Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%
Measured: during the last 15 days in symptomatic patients
Secondary outcomes (10)
Number of participants with image of lipid-rich necrotic core accounting for more than 50% of the surface of the plate on a 2D section.
identification of images of intraplaque hemorrhage (defined as an hyperintense region within the plaque on a T1-weighted sequence), lipid-rich necrotic core (accounting for more than 50% of the surface of the plate on a 2D section), or thinning/rupture of the fibrous cap (identified on a T1-weighted sequence following intravenous gadolinium administration) in High Resolution MRI by two radiologists.
Measured: during the last 15 days in symptomatic patients
Number of participants with image of intraplaque hemorrhage defined as an hyperintense region within the plaque on T1-weighted sequence.
identification of images of intraplaque hemorrhage (defined as an hyperintense region within the plaque on a T1-weighted sequence), lipid-rich necrotic core (accounting for more than 50% of the surface of the plate on a 2D section), or thinning/rupture of the fibrous cap (identified on a T1-weighted sequence following intravenous gadolinium administration) in High Resolution MRI by two radiologists.
Measured: during the last 15 days in symptomatic patients
Number of participants with image of thinning/rupture of the fibrous cap on a T1-weighted sequence following intravenous gadolinium administration.
identification of images of intraplaque hemorrhage (defined as an hyperintense region within the plaque on a T1-weighted sequence), lipid-rich necrotic core (accounting for more than 50% of the surface of the plate on a 2D section), or thinning/rupture of the fibrous cap (identified on a T1-weighted sequence following intravenous gadolinium administration) in High Resolution MRI by two radiologists.
Measured: during the last 15 days in symptomatic patients
Number of participants with image of lipid-rich necrotic core accounting for more than 50% of the surface of the plate on a 2D section.
identification of images of intraplaque hemorrhage (defined as an hyperintense region within the plaque on a T1-weighted sequence), lipid-rich necrotic core (accounting for more than 50% of the surface of the plate on a 2D section), or thinning/rupture of the fibrous cap (identified on a T1-weighted sequence following intravenous gadolinium administration) in High Resolution MRI by two radiologists.
Measured: at day 0 in asymptomatic patients
Number of participants with image of thinning/rupture of the fibrous cap on a T1-weighted sequence following intravenous gadolinium administration.
identification of images of intraplaque hemorrhage (defined as an hyperintense region within the plaque on a T1-weighted sequence), lipid-rich necrotic core (accounting for more than 50% of the surface of the plate on a 2D section), or thinning/rupture of the fibrous cap (identified on a T1-weighted sequence following intravenous gadolinium administration) in High Resolution MRI by two radiologists.
Measured: at day 0 in asymptomatic patients
Number of participants with image of intraplaque hemorrhage defined as an hyperintense region within the plaque on T1-weighted sequence.
Quantitative assessement of the wall shear stresses (WSS, measured in Pa) and oscillatory shear indexes (OSI, unitless) along the carotid wall in 3D. An accurate analysis of the hemodynamic environment will be performed using fluid dynamics mathematical models that allow the calculation of hemodynamic stress at the plate (or "wall shear stress" measured in Pascal) and temporal oscillation of the direction of this force (arbitrary units).
Measured: during the last 15 days in symptomatic patients
Quantitative assessement of the wall shear stresses (WSS, measured in Pa) along the carotid wall in 3D.
Quantitative assessement of the wall shear stresses (WSS, measured in Pa) along the carotid wall in 3D. An accurate analysis of the hemodynamic environment will be performed using fluid dynamics mathematical models that allow the calculation of hemodynamic stress at the plate (or "wall shear stress" measured in Pascal) and temporal oscillation of the direction of this force (arbitrary units).
Measured: at day 0 in asymptomatic patients
Quantitative assessement of oscillatory shear indexes (OSI, unitless) along the carotid wall in 3D.
Quantitative assessement of oscillatory shear indexes (OSI, unitless) along the carotid wall in 3D. An accurate analysis of the hemodynamic environment will be performed using fluid dynamics mathematical models that allow the calculation of hemodynamic stress at the plate (or "wall shear stress" measured in Pascal) and temporal oscillation of the direction of this force (arbitrary units).
Measured: at day 0 in asymptomatic patients
Number of participants with histological image of intraplaque hemorrhage, and/or lipid-rich necrotic core and /or thinning/rupture of the fibrous cap in surgical patients.
Measured: during the last 15 days in symptomatic patients
Measure of systemic markers of inflammation: Interleukine 1-Beta (IL1-beta), Tumor Necrosis Factor-alpha (TNF-alpha)
Measured: at Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study start15 Jan 2016
- Primary completion12 Dec 2017
- Study completion12 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery PlaqueStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norbert NIGHOGHOSSIAN, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726984
- Sponsor's protocol ID
- 69HCL15_0283
- Other IDs
- 2015-002327-26, 2015
- Acronym
- CARTIS
- Status last verified
- Aug 2025
- First submitted
- 15 Dec 2015
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mechtouff L, Sigovan M, Douek P, Costes N, Le Bars D, Mansuy A, Haesebaert J, Bani-Sadr A, Tordo J, Feugier P, Millon A, Luong S, Si-Mohamed S, Collet-Benzaquen D, Canet-Soulas E, Bochaton T, Crola Da Silva C, Paccalet A, Magne D, Berthezene Y, Nighoghossian N. Simultaneous assessment of microcalcifications and morphological criteria of vulnerability in carotid artery plaque using hybrid 18F-NaF PET/MRI. J Nucl Cardiol. 2022 Jun;29(3):1064-1074. doi: 10.1007/s12350-020-02400-0. Epub 2020 Nov 3.
PubMed 33145738
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Symptomatic and Asymptomatic Carotid Plaques Using Hybrid Imaging 18F-sodium Fluoride PET/MR
- ClinicalTrials.gov ID
- NCT02726984
- Acronym / sponsor ID
- CARTIS / 69HCL15_0283
- Conditions
- Carotid Artery Plaque
- Keywords
- stroke, carotid plaque, 18F-sodium fluoride PET/MR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 4 Apr 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | Experimental | Drug: 18F-sodium fluoride PET/MRPatients with carotid plaque ≥ 50% symptomatic (ischemic stroke on CT or MR) during the last 15 days |
| control | Experimental | Drug: 18F-sodium fluoride PET/MRPatients with asymptomatic carotid plaque ≥ 50% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| 18F-sodium fluoride PET/MR18F-sodium fluoride PET/MR combining 3Tesla (3T) MR and PET producing 127 slices of 2 mm on an axial field of view of 26 cm. 18F-sodium fluoride (2 à 4 megabecquerel/kilogram (MBq/kg)) will be injected 60 min before. | Drug | case, control |
Primary outcome
Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%
Time frame: during the last 15 days in symptomatic patients
Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%
Time frame: at day 0 in asymptomatic patients
Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%
Time frame: at day 0 in asymptomatic patients
Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%
Time frame: during the last 15 days in symptomatic patients
10 secondary outcomes
Number of participants with image of lipid-rich necrotic core accounting for more than 50% of the surface of the plate on a 2D section.
Time frame: during the last 15 days in symptomatic patients
Number of participants with image of intraplaque hemorrhage defined as an hyperintense region within the plaque on T1-weighted sequence.
Time frame: during the last 15 days in symptomatic patients
Number of participants with image of thinning/rupture of the fibrous cap on a T1-weighted sequence following intravenous gadolinium administration.
Time frame: during the last 15 days in symptomatic patients
Number of participants with image of lipid-rich necrotic core accounting for more than 50% of the surface of the plate on a 2D section.
Time frame: at day 0 in asymptomatic patients
Number of participants with image of thinning/rupture of the fibrous cap on a T1-weighted sequence following intravenous gadolinium administration.
Time frame: at day 0 in asymptomatic patients
Number of participants with image of intraplaque hemorrhage defined as an hyperintense region within the plaque on T1-weighted sequence.
Time frame: during the last 15 days in symptomatic patients
Quantitative assessement of the wall shear stresses (WSS, measured in Pa) along the carotid wall in 3D.
Time frame: at day 0 in asymptomatic patients
Quantitative assessement of oscillatory shear indexes (OSI, unitless) along the carotid wall in 3D.
Time frame: at day 0 in asymptomatic patients
Number of participants with histological image of intraplaque hemorrhage, and/or lipid-rich necrotic core and /or thinning/rupture of the fibrous cap in surgical patients.
Time frame: during the last 15 days in symptomatic patients
Measure of systemic markers of inflammation: Interleukine 1-Beta (IL1-beta), Tumor Necrosis Factor-alpha (TNF-alpha)
Time frame: at Day 0
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 4 Sep 2025.
- Results publication: PubMed 33145738Mechtouff L, Sigovan M, Douek P, Costes N, Le Bars D, Mansuy A, Haesebaert J, Bani-Sadr A, Tordo J, Feugier P, Millon A, Luong S, Si-Mohamed S, Collet-Benzaquen D, Canet-Soulas E, Bochaton T, Crola Da Silva C, Paccalet A, Magne D, Berthezene Y, Nighoghossian N. Simultaneous assessment of microcalcifications and morphological criteria of vulnerability in carotid artery plaque using hybrid 18F-NaF PET/MRI. J Nucl Cardiol. 2022 Jun;29(3):1064-1074. doi: 10.1007/s12350-020-02400-0. Epub 2020 Nov 3.
- 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.
Norbert NIGHOGHOSSIAN, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-sodium fluoride PET/MR in people with Carotid Artery Plaque, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 5 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 4 Sep 2025. 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 France. 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?
Measure of SUV (standardized uptake value) among carotid plaques ≥ 50% (time frame: during the last 15 days in symptomatic patients). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02726984, which also lists 1 linked publication.
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 4 Sep 2025.