Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging
DrugFasting XTR003 / ¹⁸F-FDG PET myocardial metabolic imaging
NCT Number: NCT07443696
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).
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Phase 2
Beijing Anzhen Hospital, Capital Medical University, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fasting XTR003 / ¹⁸F-FDG PET myocardial metabolic imaging
Glucose loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging
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.
Time frame: 6 months
include the following three items:
Time frame: 6 months
Left ventricular ejection fraction (LVEF, %)
Time frame: 6 months
Left ventricular end-diastolic diameter (LVEDD)
Time frame: 6 months
Left ventricular end-systolic diameter (LVESD)
Time frame: 6 months
Left ventricular end-diastolic volume (LVEDV, mL)
Time frame: 6 months
Left ventricular end-systolic volume (LVESV, mL)
Time frame: 6 months
Time frame: day 1
Time frame: day 1
Time frame: 6 months
Time frame: 6 months
Contact information is provided by the study sponsor or research team.
Sinotau Pharmaceutical Group
Industry
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
Acronym: STB-XTR-003
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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