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PET Imaging of Inflammation and Lipid Lowering Study

NCT04073797 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-07-19

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Cambridge University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Wellcome Trust

    collaborator OTHER

  • GE Healthcare

    collaborator INDUSTRY

  • Lund University

    collaborator OTHER

  • University of Cambridge

    lead OTHER

Principal Investigators

  • Jason M Tarkin, MBBS PhD · University of Cambridge

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2025-10-01
Completion
2026-03-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04073797 on ClinicalTrials.gov