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XTR003 PET Radiotracer for the Detection of Viable Myocardium | Clinical Trials | Clareo Health

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XTR003 PET Radiotracer for the Detection of Viable Myocardium

Exploratory Application of XTR003 as a Novel PET Myocardial Fatty Acid Metabolism Imaging Agent for the Detection of Viable Myocardium

NCT05885854•Sinotau Pharmaceutical Group

View on ClinicalTrials.gov

Summary

The study was designed to explore the clinical feasibility of XTR003, a PET myocardial fatty-acid tracer, for the detection of viable myocardium in patients with ischemic heart disease (IHD).

Detailed Description

The incidence of IHD is increasing in China and globally. However, the 18F-FDG-PET patient preparation protocols present challenges in certain patients such as patients with type I and II Diabetes Mellitus. XTR003 is a PET fatty-acid analog used in the imaging of myocardial fatty-acid metabolism. The combination of fasting XTR003/18F-FDG PET imaging may overcome the shortness of glucose-loaded 18F-FDG PET imaging protocol and effectively identify viable myocardium. This is an exploratory, single-arm, open-label, phase II clinical study with the following objectives: 1. To explore the clinical feasibility of XTR003 for the detection of viable myocardium in patients with NSTEMI, old myocardial infarction, or total occlusions of coronary arteries. 2. To evaluate the safety and adverse events incidence of XTR003 in patients with known IHD. 3. To evaluate the sensitivity and specificity of fasting 18F-FDG/XTR003 PET combining imaging in detecting viable myocardium.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18-80 years old men and women.
•2. The diagnosis and assessment of the disease meet any of the following criteria:
•(a) Patients who meet the diagnostic criteria for NSTEMI are stable and require further imaging. (b) Patients with old myocardial infarction confirmed by medical history or imaging examination and now in the stable stage. (c) Patients diagnosed with total coronary occlusions based on coronary angiography showing anterior flow occlusion segment with TIMI grade 0 or coronary CTA examination showing complete coronary artery occlusion.
•3. The rest 99mTc-Sestamibi (MIBI) SPECT imaging has been completed in the past month and no imaging technical issues were leading to poor image quality. Image indicated myocardial perfusion defect of ≥ 2 segments or total resting perfusion score (SRS) ≥4.
•4. The patient has completed glucose-loaded 18F-FDG myocardial metabolic PET imaging in the last month and has not failed to diagnose because of poor image quality due to technical problems with the imaging, except for his own glucose regulation.
•5. Patients who can communicate properly with the investigators, understand and follow the study requirements, voluntarily participate, and understand and sign the informed consent.

Exclusion Criteria

•8. Significant occupational exposure to or treatment with ionizing radiation (e.g., more than 50 mSv/yr) within 10 years.
•9. Pregnant or lactating women.
•10. People with mental disorders or poor compliance.
•11. Men and women of reproductive age refused to adopt contraceptive plans during the study period and for 6 months after the study ended.
•12. Other circumstances that the investigator considers inappropriate for participating in the study.

Locations (1)

TEDA International Cardiovascular Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

December 15, 2021

Primary Completion Date

March 4, 2023

Completion Date

March 5, 2023

Last Updated

June 2, 2023

Enrollment

ACTUAL participants

Conditions

Ischemic Heart Disease (IHD)

Interventions

XTR003

DRUG

A Clinical Evaluation of AMJ-401

NCT07373353

Ischemic Heart Disease (IHD)

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RECRUITING

CMR Prognostic Markers in Ischemic Heart Disease

NCT07351825

Ischemic Heart Disease (IHD)Myocardial Infarction (MI)

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ACTIVE_NOT_RECRUITING

Verona Coronary Physiology Interventional Registry

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 2, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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