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

NCT07443696 | Recruiting Phase 2 DMC

• 1 other identifier: STB-XTR003-202
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

18F-FDG; XTR003; position emission tomography; myocardial metabolic imaging; myocardial viability; ischemic cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• the sensitivity and specificity of the experimental group and control group

  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.

  6 months

Secondary Outcomes (11)

• Myocardial perfusion-metabolism imaging parameters (segmental level)

  6 months

• Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization

  6 months

• Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization

  6 months

• Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization

  6 months

• Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization

  6 months

Study Arms (2)

Fasting XTR003/ ¹⁸F-FDG PET

EXPERIMENTAL

Fasting XTR003 and ¹⁸F-FDG PET combined with myocardial metabolic imaging

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

Glucose-modulated ¹⁸F-FDG PET

ACTIVE COMPARATOR

Glucose-modulated ¹⁸F-FDG PET Myocardial Metabolic Imaging

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

Interventions

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

Glucose loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging

Glucose-modulated ¹⁸F-FDG PET

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

Fasting XTR003 / ¹⁸F-FDG PET myocardial metabolic imaging

Fasting XTR003/ ¹⁸F-FDG PET

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 85 years, regardless of gender.
• Diagnosed with ischemic cardiomyopathy (ICM).
• significant coronary artery disease (CAD).
• Left ventricular systolic dysfunction, with LVEF ranging from \>20% to ≤40%
• Assessed by a team of cardiac surgeons/operators as suitable for complete revascularization.
• 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.

You may not qualify if:

• Decompensated heart failure within 48 hours prior to enrollment.
• Recent ST-segment elevation myocardial infarction (STEMI) within less than 4 weeks.
• Left ventricular aneurysm.
• Judged by the investigator as unable to complete PET examination.
• Severe renal insufficiency.
• Severe hepatic insufficiency.
• Subjects with fever or active infectious diseases who are assessed by the investigator as unsuitable for study participation.
• Pregnant or lactating women.
• Contraindications to magnetic resonance imaging (MRI), such as claustrophobia or intracorporeal metallic implants.
• Subjects with mental disorders or poor compliance.
• 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.
• Other circumstances deemed by the investigator as unsuitable for trial participation.

Sponsors & Collaborators

• Sinotau Pharmaceutical Group: lead

Study Sites (3)

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

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Tao Liu

CONTACT

+86-18101131863; tao.liu1@sinotau.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized and Open-Label

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: March 2, 2026
• Study Start: December 18, 2025
• Primary Completion: August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)