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

NCT07443696 — Phase 2, Recruiting, 40 participants, Sinotau Pharmaceutical Group

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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

Registry	NCT07443696, acronym STB-XTR-003
Status	Recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, diagnostic
Enrollment	40 (Estimated)
Sponsor	Sinotau Pharmaceutical Group (Industry)
Conditions	Ischemic Cardiomyopathy, Heart Failure
Interventions	Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging, Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging (Drug)
Dates	start 2025-12-18, primary completion 2026-08-01 (estimated), completion 2026-12-01 (estimated), first posted 2026-03-02, last updated 2026-03-02
Locations	3 sites in China

-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).

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+Arms and interventions

Arm	Type	Interventions	Description
Fasting XTR003/ ¹⁸F-FDG PET	Experimental	Drug: Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging	Fasting XTR003 and ¹⁸F-FDG PET combined with myocardial metabolic imaging
Glucose-modulated ¹⁸F-FDG PET	Active comparator	Drug: Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging	Glucose-modulated ¹⁸F-FDG PET Myocardial Metabolic Imaging

Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging (Drug): Fasting XTR003 / ¹⁸F-FDG PET myocardial metabolic imaging
Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging (Drug): Glucose loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging

+Outcome measures

Primary outcomes

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.

Secondary outcomes

Myocardial perfusion-metabolism imaging parameters (segmental level) [6 months]: include the following three items: 1. summed rest score 2. summed FDG score 3. summed rest score minus summed FDG score
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization [6 months]: Left ventricular ejection fraction (LVEF, %)
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization [6 months]: Left ventricular end-diastolic diameter (LVEDD)
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization [6 months]: Left ventricular end-systolic diameter (LVESD)
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization [6 months]: Left ventricular end-diastolic volume (LVEDV, mL)
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization [6 months]: Left ventricular end-systolic volume (LVESV, mL)
Changes in New York Heart Association Functional Classification (NYHA) [6 months]
Duration Required for PET Myocardial Metabolic Imaging in the Two Groups (min) [day 1]
PET Myocardial Metabolic Imaging Quality [day 1]
Resting MPI of perfusion abnormality [6 months]
Major adverse cardiac events (MACE) [6 months]

+Eligibility

Sex: All, ages: 18 Years to 85 Years

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.

+Locations (3)

Facility	City	Country	Status
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