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XTR003 PET Radiotracer for the Detection of Viable Myocardium

Primary Purpose

Ischemic Heart Disease (IHD)

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
XTR003
Sponsored by
Sinotau Pharmaceutical Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ischemic Heart Disease (IHD) focused on measuring Coronary Artery Disease (CAD), Positron Emission Tomography (PET), XTR003 PET myocardial fatty-acid tracer, 18F-Fluorodeoxyglucose (18F-FDG), Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), Old Myocardial Infarction (OMI), Total Coronary Occlusions (TCO)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18-80 years old men and women. 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. 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. 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. 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: Patients with other preexisting cardiovascular diseases including but not limited to dilated or hypertrophic cardiomyopathy, pericarditis, aortic dissection, uncontrolled severe arrhythmias, and congenital heart disease are deemed not eligible for the study by the principal investigator. Patients with severe acute or chronic lung disease, including but not limited to chronic obstructive pulmonary disease, asthma, bronchiectasis, emphysema, pulmonary fibrosis, pulmonary embolism, pneumonia, etc., are deemed not eligible for the study by the principal investigator. Patients with severe or unstable central nervous system diseases, including but not limited to unstable cerebrovascular diseases, active epilepsy, infectious diseases of the central nervous system, and central nervous system, and central nervous system disease associated with neuropathy or limb movement disorders are deemed not eligible for the study by the principal investigator. Patients with severe hemorrhagic diseases or coagulation disorders, including but not limited to purpura, hemophilia, and deficiency in vitamin K are deemed not eligible for the study by the principal investigator. Patients with fever or active infectious diseases are deemed not eligible for the study by the principal investigator. Patients with serious disorders of organ systems other than those described above and who are deemed not eligible for the study by the principal investigator. Hematologic antigen/antibody test meets either of the following criteria: anti- HIV antibody (+) and syphilis antibody (+) are deemed not eligible for the study by the principal investigator. Significant occupational exposure to or treatment with ionizing radiation (e.g., more than 50 mSv/yr) within 10 years. Pregnant or lactating women. People with mental disorders or poor compliance. Men and women of reproductive age refused to adopt contraceptive plans during the study period and for 6 months after the study ended. Other circumstances that the investigator considers inappropriate for participating in the study.

Sites / Locations

  • TEDA International Cardiovascular Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XTR003; At rest

Arm Description

Injection with XTR003 to investigate myocardial fatty-acid metabolism in patients with known IHD. Adjunct injection with 18F-FDG to investigate and trace myocardial glucose metabolism in patients with known IHD. The study population consisted of 50 participants from the following category of patients: (1) Patients with Non-ST elevation myocardial infarction (NSTEMI) (2) Patients with old myocardial infarction (3) Patients with total occlusions of coronary arteries.

Outcomes

Primary Outcome Measures

To investigate the sensitivity of combining XTR003/FDG PET imaging
To simultaneously trace fatty-acid and glucose metabolisms for the detection of viable myocardium in IHD patients with NSTEMI, old myocardial infarction, or total occlusions of coronary arteries.
To investigate the specificity of combining XTR003/FDG PET imaging
To simultaneously trace fatty-acid and glucose metabolisms for the detection of viable myocardium in IHD patients with NSTEMI, old myocardial infarction, or total occlusions of coronary arteries.

Secondary Outcome Measures

Number of study participants with treatment-related adverse events as determined by safety parameter changes according to CTCAE v5.0
Safety parameters included adverse events, vital signs (body temperature, blood pressure, respiration rate, pulse rate), physical examinations, laboratory tests (serum cardiac biomarkers, cardiac troponin I, serum biochemistry, haematology, and urinalysis) and electrocardiograms.

Full Information

First Posted
December 25, 2022
Last Updated
May 23, 2023
Sponsor
Sinotau Pharmaceutical Group
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1. Study Identification

Unique Protocol Identification Number
NCT05885854
Brief Title
XTR003 PET Radiotracer for the Detection of Viable Myocardium
Official Title
Exploratory Application of XTR003 as a Novel PET Myocardial Fatty Acid Metabolism Imaging Agent for the Detection of Viable Myocardium
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
March 4, 2023 (Actual)
Study Completion Date
March 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinotau Pharmaceutical Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: 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. To evaluate the safety and adverse events incidence of XTR003 in patients with known IHD. To evaluate the sensitivity and specificity of fasting 18F-FDG/XTR003 PET combining imaging in detecting viable myocardium.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease (IHD)
Keywords
Coronary Artery Disease (CAD), Positron Emission Tomography (PET), XTR003 PET myocardial fatty-acid tracer, 18F-Fluorodeoxyglucose (18F-FDG), Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), Old Myocardial Infarction (OMI), Total Coronary Occlusions (TCO)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XTR003; At rest
Arm Type
Experimental
Arm Description
Injection with XTR003 to investigate myocardial fatty-acid metabolism in patients with known IHD. Adjunct injection with 18F-FDG to investigate and trace myocardial glucose metabolism in patients with known IHD. The study population consisted of 50 participants from the following category of patients: (1) Patients with Non-ST elevation myocardial infarction (NSTEMI) (2) Patients with old myocardial infarction (3) Patients with total occlusions of coronary arteries.
Intervention Type
Drug
Intervention Name(s)
XTR003
Intervention Description
Enrolled subjects were required to fast for ≥ 6 hours before drug administration at rest; Initial intravenous injection of 18F-FDG to each subject with a dose range of 2.0-3.0 mCi (74-111 MBq). Each patient will be imaged with PET for 10 minutes at 50-70 minutes after the injection. In few minutes, a single intravenous bolus injection of XTR003 will follow and administer to each patient with a dose range of 6.0-8.0 mCi (222-296 MBq). Each patient will be immediately imaged with PET for 15 minutes.
Primary Outcome Measure Information:
Title
To investigate the sensitivity of combining XTR003/FDG PET imaging
Description
To simultaneously trace fatty-acid and glucose metabolisms for the detection of viable myocardium in IHD patients with NSTEMI, old myocardial infarction, or total occlusions of coronary arteries.
Time Frame
Day 1
Title
To investigate the specificity of combining XTR003/FDG PET imaging
Description
To simultaneously trace fatty-acid and glucose metabolisms for the detection of viable myocardium in IHD patients with NSTEMI, old myocardial infarction, or total occlusions of coronary arteries.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Number of study participants with treatment-related adverse events as determined by safety parameter changes according to CTCAE v5.0
Description
Safety parameters included adverse events, vital signs (body temperature, blood pressure, respiration rate, pulse rate), physical examinations, laboratory tests (serum cardiac biomarkers, cardiac troponin I, serum biochemistry, haematology, and urinalysis) and electrocardiograms.
Time Frame
Up to 9 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-80 years old men and women. 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. 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. 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. 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: Patients with other preexisting cardiovascular diseases including but not limited to dilated or hypertrophic cardiomyopathy, pericarditis, aortic dissection, uncontrolled severe arrhythmias, and congenital heart disease are deemed not eligible for the study by the principal investigator. Patients with severe acute or chronic lung disease, including but not limited to chronic obstructive pulmonary disease, asthma, bronchiectasis, emphysema, pulmonary fibrosis, pulmonary embolism, pneumonia, etc., are deemed not eligible for the study by the principal investigator. Patients with severe or unstable central nervous system diseases, including but not limited to unstable cerebrovascular diseases, active epilepsy, infectious diseases of the central nervous system, and central nervous system, and central nervous system disease associated with neuropathy or limb movement disorders are deemed not eligible for the study by the principal investigator. Patients with severe hemorrhagic diseases or coagulation disorders, including but not limited to purpura, hemophilia, and deficiency in vitamin K are deemed not eligible for the study by the principal investigator. Patients with fever or active infectious diseases are deemed not eligible for the study by the principal investigator. Patients with serious disorders of organ systems other than those described above and who are deemed not eligible for the study by the principal investigator. Hematologic antigen/antibody test meets either of the following criteria: anti- HIV antibody (+) and syphilis antibody (+) are deemed not eligible for the study by the principal investigator. Significant occupational exposure to or treatment with ionizing radiation (e.g., more than 50 mSv/yr) within 10 years. Pregnant or lactating women. People with mental disorders or poor compliance. Men and women of reproductive age refused to adopt contraceptive plans during the study period and for 6 months after the study ended. Other circumstances that the investigator considers inappropriate for participating in the study.
Facility Information:
Facility Name
TEDA International Cardiovascular Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300456
Country
China

12. IPD Sharing Statement

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XTR003 PET Radiotracer for the Detection of Viable Myocardium

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