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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by University of Cambridge
Sponsor:
Information provided by (Responsible Party):
James Rudd, University of Cambridge
ClinicalTrials.gov Identifier:
NCT02021188
First received: December 16, 2013
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

This VISION study aims to investigate the role of inflammation in atherosclerosis using 68Ga- DOTANOC PET, and to validate 68Ga-DOTANOC 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-DOTANOC PET signal and the underlying degree of carotid inflammation measured by immunohistochemical analysis.


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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Vascular Inflammation Imaging Using Somatostatin Receptor Positron Emission Tomography Study

Resource links provided by NLM:


Further study details as provided by University of Cambridge:

Primary Outcome Measures:
  • Correlation of 68Ga-DOTANOC PET signal to carotid plaque inflammation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This primary outcome measure is correlation between carotid artery 68Ga-DOTANOC PET signal (TBR) and the underlying degree of carotid inflammation, measured by CD68 immunohistochemistry, in patients undergoing carotid endarterectomy.


Secondary Outcome Measures:
  • Comparison of 68Ga-DOTANOC signal between symptomatic and asymptomatic carotid plaques [ Time Frame: Baseline (<1 month from event) ] [ Designated as safety issue: No ]
  • Correlation of carotid artery and coronary artery 68Ga-DOTANOC uptake [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Correlation of Framingham Cardiovascular Risk Scores to arterial 68Ga-DOTANOC uptake [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Correlation between carotid artery 68Ga-DOTANOC autoradiographic signal and degree of carotid inflammation, measured by CD68 immunohistochemistry [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Comparison of myocardial 68Ga-DOTANOC and 18F-FDG uptake [ Time Frame: Baseline (2 scans within 1 week) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Carotid artery plaques


Estimated Enrollment: 50
Study Start Date: March 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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-DOTANOC, are more specific for inflammation and also lack myocardial muscle uptake. 68Ga-DOTANOC 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-DOTANOC. 50 subjects with atherosclerosis will undergo sequential PET/CT imaging with 68Ga-DOTANOC 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-DOTANOC 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02021188

Locations
United Kingdom
Cambridge University Hospitals NHS Foundation Trust Not yet recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: James HF Rudd    +44(0)1223331504    jhfr2@cam.ac.uk   
Contact: Jason M Tarkin    +44(0)1223331504    jt545@cam.ac.uk   
Sub-Investigator: Jason M Tarkin         
Sub-Investigator: Francis R Joshi         
Sub-Investigator: Ashley M Groves         
Sub-Investigator: Peter J Kirkpatrick         
Sub-Investigator: John R Buscombe         
Sub-Investigator: Tim D Fryer         
Sub-Investigator: Franklin Aigbirhio         
Sub-Investigator: Anthony P Davenport         
Sub-Investigator: Elizabeth A Warburton         
Principal Investigator: James HF Rudd         
Sponsors and Collaborators
University of Cambridge
Investigators
Principal Investigator: James HF Rudd, PhD, MRCP University of Cambridge
  More Information

No publications provided

Responsible Party: James Rudd, HEFCE Senior Lecturer and Honorary Consultant Cardiologist, University of Cambridge
ClinicalTrials.gov Identifier: NCT02021188     History of Changes
Other Study ID Numbers: A093095
Study First Received: December 16, 2013
Last Updated: December 19, 2013
Health Authority: United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Keywords provided by University of Cambridge:
Vascular inflammation
Atherosclerosis
Positron Emission Tomography
Molecular Imaging
68Ga-DOTANOC

Additional relevant MeSH terms:
Atherosclerosis
Ischemic Attack, Transient
Inflammation
Stroke
Angina Pectoris
Acute Coronary Syndrome
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Chest Pain
Pain
Signs and Symptoms
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014