Detection of Atherosclerotic Inflammation by 68Ga-DOTATATE PET Compared to [18F]FDG PET Imaging.
Jason M Tarkin, Francis R Joshi, Nicholas R Evans...
https://pubmed.ncbi.nlm.nih.gov/28385306Actively Recruiting
Phase Not Applicable
Age: 18Years - 99Years
All Genders
ID04073797
PET Imaging of Inflammation and Lipid Lowering Study in Patients with Stable Cardiovascular Disease and Elevated LDL Cholesterol
Led by University of Cambridge · Updated on 2024-07-19
63
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
U
University of Cambridge
Lead Sponsor
C
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a new imaging method to measure vascular inflammation in people with high cholesterol and stable cardiovascular disease who have elevated LDL cholesterol despite maximum statin treatment. The study aims to evaluate 68Ga-DOTATATE PET imaging, which targets inflammation more specifically than the commonly used 18F-FDG PET, and to assess changes after treatment with inclisiran or colchicine. The study also explores a novel ultrasound technique, Ultrasound Plaque Structure Analysis (UPSA), to analyze carotid artery plaque composition. Participants will be randomly assigned to one of three groups: receiving inclisiran injection plus a placebo tablet, a placebo injection plus colchicine tablet, or placebo injection plus placebo tablet. The study involves carotid artery PET-MRI scans using 68Ga-DOTATATE and carotid ultrasound with the UPSA method at the start and after 12 weeks to observe changes in arterial inflammation and plaque. During the trial, participants will undergo imaging assessments including PET-MRI and ultrasound at baseline and 12 weeks. Researchers will measure arterial inflammation, plaque burden, and compare imaging findings with blood lipid levels and inflammation markers. The study involves close monitoring to assess safety and treatment effects over the 12-week period, with participant involvement limited to scheduled imaging, clinical evaluations, and stable medication use.
CONDITIONS
Brief Title
PET Imaging of Inflammation and Lipid Lowering Study
Who Can Participate
Age: 18Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female participants over 18 years old
- Able to give written informed consent and lie flat for imaging
- Diagnosed with primary hypercholesterolaemia (non-familial or familial) or mixed dyslipidaemia
- History of cardiovascular disease such as acute coronary syndrome, revascularisation, coronary heart disease, ischemic stroke, or peripheral arterial disease
- Elevated LDL cholesterol of 2.6 mmol/L or higher despite maximum tolerated statins with or without other lipid lowering therapies
- Lipid lowering therapy unchanged for at least 6 weeks before screening
- Pre-existing carotid atherosclerotic plaque 15 mm or larger by ultrasound
You will not qualify if you...
- Women of childbearing potential not using adequate contraception
- Contraindication to MRI scanning
- Statin-associated muscle inflammation or liver function abnormalities
- Currently taking inclisiran or colchicine
- Sensitivity or contraindication to inclisiran or colchicine, including severe liver or kidney problems, blood disorders, or taking certain inhibitors
- Allergy to contrast agents or contrast-related kidney problems
- Chronic kidney disease with eGFR below 30 mL/min/1.73 m2
- Cardiovascular event within the last 6 months
- Any medical condition preventing lying flat for scans or study participation
- Uncontrolled chronic inflammatory disorders
- Recent cancer relevant to the study
- Use of medications causing significant drug interactions with study drugs
- Current use of systemic corticosteroids or other immunosuppressive drugs
- Previous or planned carotid artery surgery or stenting on the study side
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Baseline assessment
Participants undergo carotid artery 68Ga-DOTATATE PET-MRI and carotid ultrasound imaging using the Ultrasound Plaque Structure Analysis (UPSA) method to assess vascular inflammation and plaque composition before treatment.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive assigned treatments: a single injection of inclisiran or placebo injection, along with daily colchicine tablet or placebo tablet, to evaluate drug effects on arterial inflammation and lipid levels.
Daily medication intake with 1 injection at start
Diagnostic Evaluation
Duration - At 12 weeks
Repeat carotid artery 68Ga-DOTATATE PET-MRI and carotid UPSA imaging to measure changes in arterial inflammation and plaque composition after treatment.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Cambridge
Cambridge, United Kingdom
Actively Recruiting
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Research Team
J
Jason M Tarkin, MBBS PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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Published Research Related To This Trial
64Cu-DOTATATE PET/MRI for Detection of Activated Macrophages in Carotid Atherosclerotic Plaques: Studies in Patients Undergoing Endarterectomy.
Sune Folke Pedersen, Benjamin Vikjær Sandholt, Sune Høgild Keller...
https://pubmed.ncbi.nlm.nih.gov/25977567