PET imaging with XTR003 and 18F-FDG to find recoverable heart muscle 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

This trial tests whether adding XTR003 injection to 18F‑FDG PET scans helps identify living heart muscle in adults (18–85) with ischemic cardiomyopathy who are candidates for complete revascularization.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Sinotau Pharmaceutical Group (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT07443696 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, open‑label Phase IIb study enrolling 40–60 patients with ischemic cardiomyopathy and reduced LVEF who are suitable for complete revascularization. Participants are randomized 1:1 to a fasting XTR003 plus 18F‑FDG PET protocol or a glucose‑loaded 18F‑FDG PET protocol, with resting myocardial perfusion imaging combined with metabolic PET in both arms. Segmental perfusion defects, metabolic activity and myocardial viability will be analyzed by standard nuclear cardiology methods, and regional and global LV function will be measured by cardiac MRI and echocardiography before and after revascularization within six months. A repeat resting MPI will be performed to document any improvement in perfusion after revascularization.

Who should consider this trial

Good fit: Adults aged 18–85 with ischemic cardiomyopathy, significant coronary artery disease, LVEF >20% to ≤40%, and deemed suitable for complete revascularization are the intended participants.

Not a fit: Patients with recent decompensated heart failure, STEMI within four weeks, left ventricular aneurysm, severe renal or hepatic insufficiency, fever/active infection, or inability to complete PET imaging are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could help doctors better identify heart muscle likely to recover after revascularization and improve selection for procedures.

How similar studies have performed: 18F‑FDG PET is an established method for detecting viable myocardium, but combining it with XTR003 is exploratory and has limited prior clinical data.

Eligibility criteria

Inclusion Criteria:

1. Aged 18 to 85 years, regardless of gender.
2. Diagnosed with ischemic cardiomyopathy (ICM).
3. significant coronary artery disease (CAD).
4. Left ventricular systolic dysfunction, with LVEF ranging from \>20% to ≤40%
5. Assessed by a team of cardiac surgeons/operators as suitable for complete revascularization.
6. Capable of effective communication with the investigators, able to understand and comply with the clinical study requirements, voluntarily participate in the study, and provide written informed consent after being fully informed.

Exclusion Criteria:

1. Decompensated heart failure within 48 hours prior to enrollment.
2. Recent ST-segment elevation myocardial infarction (STEMI) within less than 4 weeks.
3. Left ventricular aneurysm.
4. Judged by the investigator as unable to complete PET examination.
5. Severe renal insufficiency.
6. Severe hepatic insufficiency.
7. Subjects with fever or active infectious diseases who are assessed by the investigator as unsuitable for study participation.
8. Pregnant or lactating women.
9. Contraindications to magnetic resonance imaging (MRI), such as claustrophobia or intracorporeal metallic implants.
10. Subjects with mental disorders or poor compliance.
11. Significant occupational exposure to ionizing radiation (e.g., exceeding 50 mSv per year) or exposure to radioactive substances/ionizing radiation for therapeutic or research purposes within the past 10 years.
12. Other circumstances deemed by the investigator as unsuitable for trial participation.

Where this trial is running

Beijing, Beijing Municipality and 2 other locations

• Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Chaoyang Hospital, Capital Medical University — Beijing, China (Not_yet_recruiting)
• TEDA International Cardiovascular Hospital — Tianjin, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Tao Liu

Conditions Ischemic Cardiomyopathy; Heart Failure; 18F-FDG; XTR003; position emission tomography; myocardial metabolic imaging; myocardial viability; ischemic cardiomyopathy