PET Imaging of Inflammation and Lipid Lowering Study
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- STATUS
- Recruiting
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- End date
- Mar 1, 2024
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- participants needed
- 56
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- sponsor
- University of Cambridge
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 Identifier | NCT04073797 |
| Sponsor | University of Cambridge |
| Last Modified on | 30 August 2021 |
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