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Vascular Inflammation Imaging Using Somatostatin Receptor Positron Emission Tomography (VISION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02021188
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : August 24, 2016
Information provided by (Responsible Party):
James Rudd, University of Cambridge

Brief Summary:
This VISION study aims to investigate the role of inflammation in atherosclerosis using 68Ga- DOTATATE PET, and to validate 68Ga-DOTATATE PET imaging for the detection and quantification of vascular inflammation in the aorta, coronary and carotid arteries. This study will test the hypothesis that in subjects undergoing carotid endarterectomy for symptomatic plaques, there will be a positive correlation between carotid artery 68Ga-DOTATATE PET signal and the underlying degree of carotid inflammation measured by immunohistochemical analysis.

Condition or disease
Atherosclerosis Stroke Transient Ischemic Attack Chronic Stable Angina Acute Coronary Syndrome

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Vascular Inflammation Imaging Using Somatostatin Receptor Positron Emission Tomography Study
Study Start Date : August 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Correlation of 68Ga-DOTATATE PET signal to carotid plaque inflammation [ Time Frame: 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.

Secondary Outcome Measures :
  1. Comparison of 68Ga-DOTATATE signal between symptomatic and asymptomatic carotid plaques [ Time Frame: Baseline (<1 month from event) ]
  2. Correlation of carotid artery and coronary artery 68Ga-DOTATATE uptake [ Time Frame: Baseline ]
  3. Correlation of Framingham Cardiovascular Risk Scores to arterial 68Ga-DOTATATE uptake [ Time Frame: Baseline ]
  4. Correlation between carotid artery 68Ga-DOTATATE autoradiographic signal and degree of carotid inflammation, measured by CD68 immunohistochemistry [ Time Frame: Baseline ]
  5. Comparison of myocardial 68Ga-DOTATATE and 18F-FDG uptake [ Time Frame: Baseline (2 scans within 1 week) ]

Biospecimen Retention:   Samples With DNA
Carotid artery plaques

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will recruit participants with recent transient ischaemic attack or stroke due to carotid artery disease, from which they have made a good functional recovery. A proportion of these patients will undergo carotid endarterectmy as part of clinical management. We will also recruit participants with asymptomatic carotid atheroma, and those with stable coronary artery disease or recent acute coronary syndrome.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02021188

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United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
University of Cambridge
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Principal Investigator: James HF Rudd, PhD, FRCP University of Cambridge
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: James Rudd, HEFCE Senior Lecturer and Honorary Consultant Cardiologist, University of Cambridge Identifier: NCT02021188    
Other Study ID Numbers: A093095
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Keywords provided by James Rudd, University of Cambridge:
Vascular inflammation
Positron Emission Tomography
Molecular Imaging
Additional relevant MeSH terms:
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Ischemic Attack, Transient
Acute Coronary Syndrome
Angina, Stable
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Neurologic Manifestations
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases