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COMPLETED
NCT04073797
NA

PET Imaging of Inflammation and Lipid Lowering Study

Sponsor: University of Cambridge

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-03-20

Completion Date

2026-05-30

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

DRUG

Inclisiran

Inclisiran 284 mg, one injection

DIAGNOSTIC_TEST

68Ga-DOTATATE PET-MRI

68Ga-DOTATATE PET-MRI at baseline and 12 weeks

DRUG

Colchicine

Colchicine 500 mcg tablet once daily

Locations (1)

University of Cambridge

Cambridge, United Kingdom