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

2018년 7월 10일 업데이트: Hospices Civils de Lyon

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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

15

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 프랑스
      • Bron, 프랑스, 69500
        • Hospices Civils de Lyon

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 특수 증상
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: case
Patients with carotid plaque ≥ 50% symptomatic (ischemic stroke on CT or MR) during the last 15 days
의약품: 18F-sodium fluoride PET/MR
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.
실험적: control
Patients with asymptomatic carotid plaque ≥ 50%
의약품: 18F-sodium fluoride PET/MR
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%
기간: during the last 15 days in symptomatic patients
during the last 15 days in symptomatic patients
Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%
기간: at day 0 in asymptomatic patients
at day 0 in asymptomatic patients
Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%
기간: at day 0 in asymptomatic patients
at day 0 in asymptomatic patients
Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%
기간: during the last 15 days in symptomatic patients
during the last 15 days in symptomatic patients

2차 결과 측정

결과 측정
측정값 설명
기간
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.
기간: during the last 15 days in symptomatic patients
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.
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.
기간: during the last 15 days in symptomatic patients
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.
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.
기간: during the last 15 days in symptomatic patients
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.
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.
기간: at day 0 in asymptomatic patients
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.
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.
기간: at day 0 in asymptomatic patients
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.
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.
기간: during the last 15 days in symptomatic patients
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).
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.
기간: at day 0 in asymptomatic patients
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).
at day 0 in asymptomatic patients
Quantitative assessement of oscillatory shear indexes (OSI, unitless) along the carotid wall in 3D.
기간: at day 0 in asymptomatic patients
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).
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.
기간: during the last 15 days in symptomatic patients
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)
기간: at Day 0
at Day 0

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hospices Civils de Lyon

수사관

  • 수석 연구원: Norbert NIGHOGHOSSIAN, Pr, Hospices Civils de Lyon

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 1월 15일

기본 완료 (실제)

2017년 12월 12일

연구 완료 (실제)

2017년 12월 12일

연구 등록 날짜

최초 제출

2015년 12월 15일

QC 기준을 충족하는 최초 제출

2016년 3월 29일

처음 게시됨 (추정)

2016년 4월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 7월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 7월 10일

마지막으로 확인됨

2018년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 69HCL15_0283
  • 2015-002327-26 (EudraCT 번호)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

경동맥 플라크에 대한 임상 시험

18F-sodium fluoride PET/MR에 대한 임상 시험

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건강 상태

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정황

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약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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