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TerminatedPhase 2

Comparative Imaging of XTR004 PET and MIBI SPECT in Borderline Coronary Stenosis

Key facts

Who runs it
Sinotau Pharmaceutical Group
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Status
Terminated
Phase
Phase 2
People taking part
17 people enrolled
Started
19 Dec 2024
Ended
5 Mar 2025
Type of study
Interventional
Treatments tested
  • XTR004
Record updated
12 January 2026
Why it stopped
The main objective of this study has been achieved. Following internal discussions, the sponsor has decided to terminate this study early.

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 1.Male or female participants aged 18 years or older
  • 2.Suspected or known stable coronary artery disease with related symptoms and stable condition, and having at least one coronary artery disease risk factor, including: hypertension, hyperlipidemia, diabetes, obesity, alcohol abuse, smoking, family history of coronary artery disease, postmenopausal status in women, or advanced age
  • 3.Underwent coronary CTA within the past 6 months showing 30%-90% stenosis, or indicating mild to moderate-to-severe stenosis
  • 4.Able to communicate effectively with the investigators, understand and comply with the clinical study requirements, voluntarily participate in the study, and provide written informed consent

Who cannot take part

  • 2.Patients with a prior diagnosis of myocardial infarction, congenital heart disease, cardiomyopathy, myocarditis, or other cardiac diseases
  • 6.Individuals with significant occupational exposure to ionizing radiation within the past 10 years (e.g., exceeding 50 mSv/year), or exposure to radioactive substances or ionizing radiation for therapeutic or research purposes
  • 10.Patients who participated in another investigational drug clinical study within 30 days prior to enrollment or plan to do so during follow-up
  • 1. Patients with a history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
  • 3.Patients known to have severe allergic reactions to alcohol
  • 4.Patients known to have an allergy or other contraindications to adenosine
  • 5.Patients known to be allergic to iodinated contrast agents
  • 9.Patients with claustrophobia, bipolar disorder, other psychiatric disorders, or poor compliance
  • 11.Any other condition that, in the opinion of the investigators, makes the patient unsuitable for participation
  • 7.Men and women of childbearing potential who do not plan to use effective contraception during the study and for 6 months after study completion (effective methods include sterilization, intrauterine hormonal devices, condoms, contraceptive pills/agents, abstinence, or partner vasectomy/tubal ligation)
  • 8.Pregnant or lactating women

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Compare the diagnostic certainty of MIBI SPECT myocardial perfusion imaging (MPI) and XTR004 PET MPI.

The group in the trial

  • XTR004 MPI PET & MIBI SPECT MPITreatment being tested

    Patients with suspected or known stable coronary artery disease who have previously undergone coronary CTA showing 30%-80% stenosis in any coronary vessel, or mild to moderate stenosis, will be enrolled and sequentially undergo MIBI SPECT myocardial perfusion imaging (MPI) and XTR004 PET MPI

    Treatment: XTR004

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Comparative Imaging Study of PET Myocardial Perfusion With XTR004 Injection Versus MIBI SPECT in Patients With Borderline Coronary Stenosis
Record updated
12 January 2026