NCT07443696

PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection and 18F-FDG to Assess Myocardial Viability in Ischemic Cardiomyopathy

A Randomized, Open-Label, Parallel-Controlled Phase IIb Clinical Trial of PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection Integrated With 18F-FDG for the Assessment of Myocardial Viability in Patients With Ischemic Cardiomyopathy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sinotau Pharmaceutical Group · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized, open-label, parallel-controlled Phase IIb study to investigate the diagnostic-prognostic utility of XTR003 Injection integrated with 18F-FDG as an exploratory clinical trial. A total of 40-60 patients will be enrolled and randomized into two study groups as: fasting XTR003/18F-FDG group and glucose-loaded group at a 1:1 ratio. Each group will receive resting myocardial perfusion imaging (MPI) combined with metabolic PET imaging to evaluate myocardial metabolic activity and myocardial viability. Segmental perfusion abnormality, metabolic activity and myocardial viability will be analyzed according to the standard approaches in Nuclear Cardiology. Regional and global left ventricular function will be assessed with cardiac MRI and echocardiography prior to and post the completion of full revascularization within 6-month time point. A repeated resting MPI will also be performed to assess the improvement of perfusion abnormality. All study subjects will undergo 6 months follow-up for major adverse cardiac events (MACE).

Conditions

• Ischemic Cardiomyopathy
• Heart Failure

Interventions

Type	Name	Description
DRUG	Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging	Fasting XTR003 / ¹⁸F-FDG PET myocardial metabolic imaging
DRUG	Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging	Glucose loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging

Timeline

• Start date: 2025-12-18
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

3 sites across 1 country: China