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

December 16, 2013
December 19, 2013
March 2014
March 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02021188 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Vascular Inflammation Imaging Using Somatostatin Receptor Positron Emission Tomography
The Vascular Inflammation Imaging Using Somatostatin Receptor Positron Emission Tomography Study

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Carotid artery plaques

Non-Probability Sample

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.

  • Atherosclerosis
  • Stroke
  • Transient Ischemic Attack
  • Chronic Stable Angina
  • Acute Coronary Syndrome
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
United Kingdom
 
NCT02021188
A093095
No
James Rudd, University of Cambridge
University of Cambridge
Not Provided
Principal Investigator: James HF Rudd, PhD, MRCP University of Cambridge
University of Cambridge
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP