Vascular Inflammation Imaging Using Somatostatin Receptor Positron Emission Tomography (VISION)
The Vascular Inflammation Imaging Using Somatostatin Receptor Positron Emission Tomography Study
연구 개요
상태
상세 설명
Clinical events in atherosclerosis are largely driven by inflammation. Molecular imaging of atherosclerosis can potentially identify high-risk lesions, help guide treatment and illuminate the underlying biology of the disease. 18F-fluorodeoxyglucose (18F-FDG) PET is the gold-standard nuclear molecular imaging technique with well-established roles in atherosclerosis imaging. However, the arterial 18F-FDG signal is non-specific, although it is related to increased macrophage activity with contributions from hypoxia and angiogenesis. Coronary artery imaging with 18F-FDG is particularly difficult, mainly due to high background myocardial cell 18F-FDG uptake, which obscures interpretation of the coronary signal. Efforts to suppress myocardial 18F-FDG uptake with dietary manipulation are challenging for patients and have limited efficacy.
PET tracers currently used in cancer imaging, such as 68Ga-DOTATATE, are potentially more specific for inflammation and also lack myocardial muscle uptake. 68Ga-DOTATATE might therefore be better suited than 18F-FDG for imaging inflammation, particularly within the coronary arteries. The VISION study is a prospective, observational study designed to investigate the biology of plaque inflammation in atherosclerosis, using PET imaging with the somatostatin receptor ligand 68Ga-DOTATATE. 50 subjects with atherosclerosis will undergo sequential PET/CT imaging with 68Ga-DOTATATE and 18F-FDG, along with contrast angiography of the carotid and coronary arteries. Autoradiography and immunohistochemistry of excised carotid plaques will be used to validate the imaging data. If successful, 68Ga-DOTATATE imaging will offer a cheaper, more specific non-invasive measure of inflammation than 18F- FDG, particularly in the coronary arteries. This opens up the possibility of better risk stratification for patients with atherosclerosis and could provide a non-invasive platform to test the effects of novel anti-atherosclerosis drugs.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Cambridgeshire
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Cambridge, Cambridgeshire, 영국, CB2 0QQ
- Cambridge University Hospitals NHS Foundation Trust
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age ≥40 years of age
- Can provide written, fully informed consent
- Have had a transient ischemic attack (TIA) or stroke within the preceding four weeks due to carotid artery atherosclerosis; or have ≥30% carotid artery or epicardial coronary artery stenosis
Exclusion Criteria:
- Renal impairment (eGFR<30mls/min)
- History of contrast nephropathy
- Atrial fibrillation
- Any condition, in the opinion of the investigator, which prevents the participant from lying flat during scanning
- Women of childbearing potential
- Inability to provide written informed consent
- Haemorrhagic stroke within 3 months of study entry
- Total occlusion of a culprit carotid artery
- Any medical condition, vital sign or laboratory value that, in the opinion of the investigator, makes the subject ineligible for inclusion
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Carotid artery disease
Participants with symptomatic or asymptomatic carotid artery plaques
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Coronary artery disease
Participants with stable coronary artery disease or recent acute coronary syndrome
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Correlation of 68Ga-DOTATATE PET signal to carotid plaque inflammation
기간: Baseline
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This primary outcome measure is correlation between carotid artery 68Ga-DOTATATE PET signal (TBR) and the underlying degree of carotid inflammation, measured by CD68 immunohistochemistry, in patients undergoing carotid endarterectomy.
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Baseline
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2차 결과 측정
결과 측정 |
기간 |
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Comparison of 68Ga-DOTATATE signal between symptomatic and asymptomatic carotid plaques
기간: Baseline (<1 month from event)
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Baseline (<1 month from event)
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Correlation of carotid artery and coronary artery 68Ga-DOTATATE uptake
기간: Baseline
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Baseline
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Correlation of Framingham Cardiovascular Risk Scores to arterial 68Ga-DOTATATE uptake
기간: Baseline
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Baseline
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Correlation between carotid artery 68Ga-DOTATATE autoradiographic signal and degree of carotid inflammation, measured by CD68 immunohistochemistry
기간: Baseline
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Baseline
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Comparison of myocardial 68Ga-DOTATATE and 18F-FDG uptake
기간: Baseline (2 scans within 1 week)
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Baseline (2 scans within 1 week)
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공동 작업자 및 조사자
수사관
- 수석 연구원: James HF Rudd, PhD, FRCP, University of Cambridge
간행물 및 유용한 링크
일반 간행물
- Tarkin JM, Calcagno C, Dweck MR, Evans NR, Chowdhury MM, Gopalan D, Newby DE, Fayad ZA, Bennett MR, Rudd JHF. 68Ga-DOTATATE PET Identifies Residual Myocardial Inflammation and Bone Marrow Activation After Myocardial Infarction. J Am Coll Cardiol. 2019 May 21;73(19):2489-2491. doi: 10.1016/j.jacc.2019.02.052. No abstract available.
- Tarkin JM, Joshi FR, Evans NR, Chowdhury MM, Figg NL, Shah AV, Starks LT, Martin-Garrido A, Manavaki R, Yu E, Kuc RE, Grassi L, Kreuzhuber R, Kostadima MA, Frontini M, Kirkpatrick PJ, Coughlin PA, Gopalan D, Fryer TD, Buscombe JR, Groves AM, Ouwehand WH, Bennett MR, Warburton EA, Davenport AP, Rudd JH. Detection of Atherosclerotic Inflammation by 68Ga-DOTATATE PET Compared to [18F]FDG PET Imaging. J Am Coll Cardiol. 2017 Apr 11;69(14):1774-1791. doi: 10.1016/j.jacc.2017.01.060.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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