Vascular Inflammation Imaging Using Somatostatin Receptor Positron Emission Tomography (VISION)
The Vascular Inflammation Imaging Using Somatostatin Receptor Positron Emission Tomography Study
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Cambridgeshire
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Cambridge、Cambridgeshire、イギリス、CB2 0QQ
- Cambridge University Hospitals NHS Foundation Trust
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Correlation of 68Ga-DOTATATE PET signal to carotid plaque inflammation
時間枠：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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二次結果の測定
結果測定 |
時間枠 |
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Comparison of 68Ga-DOTATATE signal between symptomatic and asymptomatic carotid plaques
時間枠：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
時間枠：Baseline
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Baseline
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Correlation of Framingham Cardiovascular Risk Scores to arterial 68Ga-DOTATATE uptake
時間枠：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
時間枠：Baseline
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Baseline
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Comparison of myocardial 68Ga-DOTATATE and 18F-FDG uptake
時間枠：Baseline (2 scans within 1 week)
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Baseline (2 scans within 1 week)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：James HF Rudd, PhD, FRCP、University of Cambridge
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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