Vascular Inflammation Imaging Using Somatostatin Receptor Positron Emission Tomography (VISION)
The Vascular Inflammation Imaging Using Somatostatin Receptor Positron Emission Tomography Study
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, Reino Unido, CB2 0QQ
- Cambridge University Hospitals NHS Foundation Trust
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Carotid artery disease
Participants with symptomatic or asymptomatic carotid artery plaques
|
|
Coronary artery disease
Participants with stable coronary artery disease or recent acute coronary syndrome
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlation of 68Ga-DOTATATE PET signal to carotid plaque inflammation
Periodo de tiempo: Baseline
|
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.
|
Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Comparison of 68Ga-DOTATATE signal between symptomatic and asymptomatic carotid plaques
Periodo de tiempo: Baseline (<1 month from event)
|
Baseline (<1 month from event)
|
|
Correlation of carotid artery and coronary artery 68Ga-DOTATATE uptake
Periodo de tiempo: Baseline
|
Baseline
|
|
Correlation of Framingham Cardiovascular Risk Scores to arterial 68Ga-DOTATATE uptake
Periodo de tiempo: Baseline
|
Baseline
|
|
Correlation between carotid artery 68Ga-DOTATATE autoradiographic signal and degree of carotid inflammation, measured by CD68 immunohistochemistry
Periodo de tiempo: Baseline
|
Baseline
|
|
Comparison of myocardial 68Ga-DOTATATE and 18F-FDG uptake
Periodo de tiempo: Baseline (2 scans within 1 week)
|
Baseline (2 scans within 1 week)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: James HF Rudd, PhD, FRCP, University of Cambridge
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Isquemia miocardica
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Dolor
- Manifestaciones neurológicas
- Isquemia cerebral
- Dolor de pecho
- Angina de pecho
- Inflamación
- Ataque Isquémico, Transitorio
- Aterosclerosis
- El síndrome coronario agudo
- Angina, Estable
Otros números de identificación del estudio
- A093095
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .