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

NCT02726984 | Completed

• 2 other identifiers: 69HCL15_02832015-002327-26
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carotid Artery Plaque

Keywords

stroke; carotid plaque; 18F-sodium fluoride PET/MR

Outcome Measures

Primary Outcomes (4)

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

  during the last 15 days in symptomatic patients

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

  at day 0 in asymptomatic patients

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

  at day 0 in asymptomatic patients

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

  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.

  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.

  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.

  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.

  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.

  at day 0 in asymptomatic patients

Study Arms (2)

case

EXPERIMENTAL

Patients with carotid plaque ≥ 50% symptomatic (ischemic stroke on CT or MR) during the last 15 days

Drug: 18F-sodium fluoride PET/MR

control

EXPERIMENTAL

Patients with asymptomatic carotid plaque ≥ 50%

Drug: 18F-sodium fluoride PET/MR

Interventions

18F-sodium fluoride PET/MR DRUG

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.

case; control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

Related Publications (1)

• 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.

  PMID: 33145738 RESULT

MeSH Terms

Conditions

Carotid Stenosis; Stroke

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Norbert NIGHOGHOSSIAN, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: April 4, 2016
• Study Start: January 15, 2016
• Primary Completion: December 12, 2017
• Study Completion: December 12, 2017
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)