PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection and 18F-FDG to Assess Myocardial Viability in Ischemic Cardiomyopathy (STB-XTR-003)

February 26, 2026 updated by: Sinotau Pharmaceutical Group

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 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • Beijing Chaoyang Hospital, Capital Medical University
      • Tianjin, China
        • Not yet recruiting
        • Teda International Cardiovascular Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing AnZhen Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fasting XTR003/ ¹⁸F-FDG PET
Fasting XTR003 and ¹⁸F-FDG PET combined with myocardial metabolic imaging
Drug: Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging
Fasting XTR003 / ¹⁸F-FDG PET myocardial metabolic imaging
Active Comparator: Glucose-modulated ¹⁸F-FDG PET
Glucose-modulated ¹⁸F-FDG PET Myocardial Metabolic Imaging
Drug: Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging
Glucose loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the sensitivity and specificity of the experimental group and control group
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial perfusion-metabolism imaging parameters (segmental level)
Time Frame: 6 months

include the following three items:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinotau Pharmaceutical Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STB-XTR003-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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