Vascular Inflammation Imaging Using Somatostatin Receptor Positron Emission Tomography

Stroke Clinical Trial

— VISION  

Official title:

The Vascular Inflammation Imaging Using Somatostatin Receptor Positron Emission Tomography Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021188
• Other study ID #: A093095
• Status: Completed
• Phase: N/A
• First received: December 16, 2013
• Last updated: August 23, 2016
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Stable
• Atherosclerosis
• Chronic Stable Angina
• Inflammation
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of 68Ga-DOTATATE PET signal to carotid plaque inflammation	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	No
Secondary	Comparison of 68Ga-DOTATATE signal between symptomatic and asymptomatic carotid plaques		Baseline (<1 month from event)	No
Secondary	Correlation of carotid artery and coronary artery 68Ga-DOTATATE uptake		Baseline	No
Secondary	Correlation of Framingham Cardiovascular Risk Scores to arterial 68Ga-DOTATATE uptake		Baseline	No
Secondary	Correlation between carotid artery 68Ga-DOTATATE autoradiographic signal and degree of carotid inflammation, measured by CD68 immunohistochemistry		Baseline	No
Secondary	Comparison of myocardial 68Ga-DOTATATE and 18F-FDG uptake		Baseline (2 scans within 1 week)	No