NCT05885854

XTR003 PET Radiotracer for the Detection of Viable Myocardium

Exploratory Application of XTR003 as a Novel PET Myocardial Fatty Acid Metabolism Imaging Agent for the Detection of Viable Myocardium

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Sinotau Pharmaceutical Group · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study was designed to explore the clinical feasibility of XTR003, a PET myocardial fatty-acid tracer, for the detection of viable myocardium in patients with ischemic heart disease (IHD).

Detailed description

The incidence of IHD is increasing in China and globally. However, the 18F-FDG-PET patient preparation protocols present challenges in certain patients such as patients with type I and II Diabetes Mellitus. XTR003 is a PET fatty-acid analog used in the imaging of myocardial fatty-acid metabolism. The combination of fasting XTR003/18F-FDG PET imaging may overcome the shortness of glucose-loaded 18F-FDG PET imaging protocol and effectively identify viable myocardium. This is an exploratory, single-arm, open-label, phase II clinical study with the following objectives: 1. To explore the clinical feasibility of XTR003 for the detection of viable myocardium in patients with NSTEMI, old myocardial infarction, or total occlusions of coronary arteries. 2. To evaluate the safety and adverse events incidence of XTR003 in patients with known IHD. 3. To evaluate the sensitivity and specificity of fasting 18F-FDG/XTR003 PET combining imaging in detecting viable myocardium.

Conditions

• Ischemic Heart Disease (IHD)

Interventions

Type	Name	Description
DRUG	XTR003	Enrolled subjects were required to fast for ≥ 6 hours before drug administration at rest; 1. Initial intravenous injection of 18F-FDG to each subject with a dose range of 2.0-3.0 mCi (74-111 MBq). Each patient will be imaged with PET for 10 minutes at 50-70 minutes after the injection. 2. In few minutes, a single intravenous bolus injection of XTR003 will follow and administer to each patient with a dose range of 6.0-8.0 mCi (222-296 MBq). Each patient will be immediately imaged with PET for 15 minutes.

Timeline

• Start date: 2021-12-15
• Primary completion: 2023-03-04
• Completion: 2023-03-05
• First posted: 2023-06-02
• Last updated: 2023-06-02

Locations

1 site across 1 country: China