Research with gallium dotatate PET/CT scans to image atherosclerosis in the coronary arteries.

Phase 1

• Conditions: Inflammatory atherosclerosis of the coronary arteries.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2022-002269-14-NL
• Lead Sponsor: AMC, Cardiovascular Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-06
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

- Aged 50 years and older
- Underwent CCTA imaging within 78 weeks from the screening visit
- Either CAD-RADS 4 or higher or 0/1 on CCTA.
- Able to provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI
value of < 45 ml/min/1,73m2.
- CVD events/revascularization in history
- Malignant diseases or any clinically significant medical condition that
could interfere with the conduct of the study in the opinion of the
investigator.
- Chronic or recent (< 1 month) infections and/or clinical signs of acute
infection.
- History of auto-immune diseases.
- Standard contra-indications to 68Ga-Dotatate PET, and CT based on
physicians experience and current practices.
- Inability or unwillingness to comply with the protocol requirements, or
deemed by investigator to be unfit for the study.
- Elevated liver enzymes (> 2 ULN of liver transaminases), acute liver
failure or known liver disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether vulnerable coronary plaques have more uptake of<br>68Ga-Dotatate than non-vulnerable plaques.;Secondary Objective: To correlate 68Ga-Dotatate uptake with the fat attenuation index (FAI),<br>a specific CCTA parameter of vascular inflammation.;Primary end point(s): Correlation between tracer uptake and plaque vulnerability.;Timepoint(s) of evaluation of this end point: After 1 PET/Ct

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): n.a.;Timepoint(s) of evaluation of this end point: n.a.