PET Imaging of Inflammation and Lipid Lowering Study

  • STATUS
    Recruiting
  • End date
    Mar 1, 2024
  • participants needed
    56
  • sponsor
    University of Cambridge
Updated on 30 August 2021
peripheral artery disease
atorvastatin
stroke
LDL Cholesterol
acute coronary syndrome
18f-fdg
cholesterol level
cholesterol measurement
pcsk9
glucose analog

Summary

While 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging has been used as an early marker of drug efficacy in numerous clinical cardiovascular drug trials, as a glucose analog, its signal in the vasculature lacks inflammatory cell-specificity. Moreover, high background 18F-FDG signals from the myocardium often preclude coronary artery imaging, despite attempts to suppress myocardial tracer uptake by dietary manipulation. These limitations of 18F-FDG for measuring changes in vascular inflammation arising from drug intervention highlight important unmet needs, which might be overcome by using a somatostatin receptor subtype-2 (SST2) PET tracer.

Description

Up-regulation of SST2 in activated macrophages represents a novel imaging target for measuring vascular inflammation, which has been previously examined in atherosclerosis using 68Ga-DOTATATE. To test the hypothesis that 68Ga-DOTATATE can quantify drug-induced changes in arterial inflammation, patients with stable cardiovascular disease or heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein (LDL) cholesterol despite high-intensity statin treatment will undergo serial carotid 68Ga-DOTATATE PET-magnetic resonance imaging (MRI) in a double-blind, two-arm, parallel-design, placebo-controlled study.

Details
Condition High Cholesterol, hypercholesteremia, Hypercholesterolemia, Familial Hypercholesterolemia, High Cholesterol (Hyperlipidemia), FAMILIAL HYPERCHOLESTEROLEMIA, Hyperlipidemia, elevated cholesterol
Treatment PCSK9 Inhibitor, 68Ga-DOTATATE PET-MRI
Clinical Study IdentifierNCT04073797
SponsorUniversity of Cambridge
Last Modified on30 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female participants >18 years old
Able to give written, informed consent and to lie flat
Have a history of CVD (acute coronary syndrome, ischaemic stroke, transient ischaemic attack, or documented coronary, carotid, or peripheral arterial disease) and elevated LDL cholesterol despite high-intensity atorvastatin (Group 1), or
Have HeFH (definite or probable FH based on clinical criteria) and elevated LDL cholesterol despite high-intensity atorvastatin (Group 2)
Lipid lowering therapy unchanged for at least 6 weeks prior to screening

Exclusion Criteria

Women of child bearing potential not using adequate contraception
Contra-indication to MRI scanning
Statin-associated myositis or liver function abnormality
Sensitivity to PCSK9 inhibitors or monoclonal antibodies
Contrast allergy or contrast-nephropathy
Chronic kidney disease (eGFR <30 mL/min/1.73 m2)
Cardiovascular event within 6 months
Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study
Uncontrolled chronic inflammatory disorder
History of recent malignancy deemed relevant to the study by the investigator
Treatment with medications that result in significant drug to drug interactions with the study medication
Current use of systemic corticosteroids
Previous carotid endarterectomy surgery or stenting
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