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

Dotatate to locate coronary plaques at high-risk of myocardial infarction

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002269-14-NL

Enrollment

Registered

2022-08-06

Start date

2022-08-11

Completion date

Unknown

Last updated

2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory atherosclerosis of the coronary arteries.

Interventions

Trade Name: SomaKit TOC Product Name: 68Ga-Dotatate Pharmaceutical Form: Solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of 2 ULN of liver transaminases), acute liver failure or known liver disease.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether vulnerable coronary plaques have more uptake of 68Ga-Dotatate than non-vulnerable plaques.;Secondary Objective: To correlate 68Ga-Dotatate uptake with the fat attenuation index (FAI), 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	—

Measure

Time frame

Main Objective: To assess whether vulnerable coronary plaques have more uptake of 68Ga-Dotatate than non-vulnerable plaques.;Secondary Objective: To correlate 68Ga-Dotatate uptake with the fat attenuation index (FAI), 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

Measure	Time frame
Secondary end point(s): n.a.;Timepoint(s) of evaluation of this end point: n.a.	—

Countries

Netherlands

Contacts

Public ContactVascular Medicine Research

AMC

r.oostveen@amsterdamum.nl+310205667050

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026