XTR003 PET Radiotracer for the Detection of Viable Myocardium

May 23, 2023 updated by: Sinotau Pharmaceutical Group

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

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 Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300456
        • TEDA International Cardiovascular Hospital

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. 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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Patients with fever or active infectious diseases are deemed not eligible for the study by the principal investigator.
  6. 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.
  7. 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.
  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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XTR003; At rest
  1. Injection with XTR003 to investigate myocardial fatty-acid metabolism in patients with known IHD.
  2. 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.
Drug: XTR003

Enrolled subjects were required to fast for ≥ 6 hours before drug administration at rest;

  1. 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.
  2. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To investigate the sensitivity of combining XTR003/FDG PET imaging
Time Frame: Day 1
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.
Day 1
To investigate the specificity of combining XTR003/FDG PET imaging
Time Frame: Day 1
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of study participants with treatment-related adverse events as determined by safety parameter changes according to CTCAE v5.0
Time Frame: Up to 9 days
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.
Up to 9 days

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 15, 2021

Primary Completion (Actual)

March 4, 2023

Study Completion (Actual)

March 5, 2023

Study Registration Dates

First Submitted

December 25, 2022

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Estimated)

June 2, 2023

Study Record Updates

Last Update Posted (Estimated)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STB-XTR003-201

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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