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Clinical Trials in China / NCT07443696
Recruiting Phase 2

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

NCT07443696 · tracked via the Priya Life Science China tracker
Sponsor
Sinotau Pharmaceutical Group
Phase
Phase 2
Started
2025-12-18
Last updated
2026-03-02

Condition(s) studied

Ischemic CardiomyopathyHeart Failure

Investigational drug(s) / intervention(s)

Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imagingGlucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging

Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging: Fasting XTR003 / ¹⁸F-FDG PET myocardial metabolic imaging

Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging: Glucose loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging

Study 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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • the sensitivity and specificity of the experimental group and control group — 6 months
    Using the recoverable left-ventricular wall motion abnormality at 6 months post full revascularization as the reference standard to study the sensitivity and specificity of myocardial viability for predicting functional recovery in the experimental group and control group.

Trial sites (3)

FacilityCityRegionStatus
Beijing Anzhen Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Beijing Chaoyang Hospital, Capital Medical University Beijing China Not Yet Recruiting
TEDA International Cardiovascular Hospital Tianjin China Not Yet Recruiting

More Sinotau Pharmaceutical Group trials in China

A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETs Active, not recruiting
A Clinical Trial Evaluating the Safety and Tolerability, Biodistribution and Radiation Dosimetry, and Pharmacokinetics of Flotufolastat F-18 Injection in Healthy Chinese Adults Recruiting
A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms Recruiting
Comparison of Diagnostic Accuracy Between XTR004 PET MPI and the Composite Index of Quantitative Coronary Angiography (QCA) and Fractional Flow Reserve (FFR) Recruiting
Analysis of 18F-XTR006 PET Imaging in Cognitively Normal Subjects, and Patients With MCI and AD Recruiting

Other trials for the same condition

Cardiometabolic evalUation REgistry of Heart Failure Recruiting
IPSC-CMs Combined with LVAD or CABG for the Treatment of Heart Failure Starting soon
A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart Recruiting
A Pivotal Clinical Trial of Human Induced Pluripotent Stem Cell-derived Cardiomyocytes Injection (HiCM-188) for the Treatment of Advanced Heart Failure(NYHA III-IV) Recruiting
Baduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (BESMILE-HF Study) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07443696 on ClinicalTrials.gov ↗ ← All trials in China