RecruitingPhase 2NCT07443696

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

Sponsor

Sinotau Pharmaceutical Group

Enrollment

40 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure Ischemic Cardiomyopathy

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).

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is using special PET scan imaging with two tracers — a new fatty acid tracer (XTR003) and the standard glucose tracer (18F-FDG) — to see which areas of the heart muscle are still alive (viable) but not working properly in people with ischemic cardiomyopathy (heart muscle damage caused by blocked arteries). Identifying viable heart muscle helps surgeons decide who will benefit from bypass surgery. **You may be eligible if...** - You are between 18 and 85 years old - You have been diagnosed with ischemic cardiomyopathy (heart damage from blocked coronary arteries) - You have significant coronary artery disease - Your heart's pumping function is reduced (ejection fraction between 20% and 40%) - A heart surgery team has assessed you as suitable for full revascularization (bypass or stenting) - You are able to cooperate with study procedures and provide written consent **You may NOT be eligible if...** - You had severe heart failure or a major heart attack (STEMI) in the last 4 weeks - You have a large bulge (aneurysm) in the heart wall - You have severe kidney or liver failure - You have active fever or infection - You are pregnant or breastfeeding - You have claustrophobia or metal implants preventing MRI - You have significant occupational radiation exposure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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