XTR004 PET heart scan to detect flow‑limiting coronary blockages
Official title: Evaluation of the Efficacy and Safety of XTR004 Injection in Detecting Blood Flow Restrictive Stenosis in Patients With Suspected or Known Stable Coronary Artery Disease: A Multicenter, Open-Label, Phase III Clinical Trial
Run by Sinotau Pharmaceutical Group · NCT07439133 · Data updated 2026-11-12
This trial tests whether XTR004 PET heart scans can accurately detect significant coronary artery blockages in adults with suspected or known coronary artery disease compared with QCA and FFR.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 395 (estimated) |
| Sponsor | Sinotau Pharmaceutical Group Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 5 sites (Beijing and 4 other locations) |
| Status | Recruiting |
| Started | November 14, 2025 |
| Main results expected | June 2027 |
| Study ends | October 2027 |
| Registry record updated | March 3, 2026 |
| Trial ID | NCT07439133 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–80 with suspected or confirmed stable coronary artery disease who meet the listed risk‑factor criteria and can give informed consent are the intended participants.
✕Probably not a fit
Patients with severe unstable cardiac conditions, uncontrolled hypertension, hypotension, or other exclusionary comorbidities are unlikely to be eligible or to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 3 interventional diagnostic study comparing visual readings of XTR004 PET myocardial perfusion imaging (MPI) against a composite reference standard of quantitative coronary angiography (QCA) and fractional flow reserve (FFR) for detecting restrictive coronary stenoses. Adults aged 18–80 with suspected or confirmed stable coronary artery disease and relevant risk factors are enrolled and undergo XTR004 PET imaging plus invasive angiography/FFR. The primary outcome is diagnostic accuracy of visual PET interpretation for identifying flow‑limiting lesions. The trial is conducted at several major Beijing hospitals and sponsored by Sinotau Pharmaceutical Group.
Why it matters
Potential benefit: If successful, XTR004 PET could provide a noninvasive, accurate way to identify flow‑limiting coronary stenoses and help guide treatment decisions.
How similar studies have gone: Other PET myocardial perfusion approaches (e.g., rubidium‑82 or N‑13 ammonia PET) have shown good concordance with FFR for detecting ischemia, but XTR004 is a novel agent that requires phase 3 validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants aged 18 to 80 years, male or female. * Suspected or confirmed patients with stable coronary heart disease. Those suspected of having stable coronary heart disease must meet at least one of the following risk factors: hypertension, hyperlipidemia, diabetes, obesity (BMI ≥28), a history of alcohol abuse, a smoking history, a family history of coronary heart disease, postmenopausal status, or age 60 years or older. * Participants can communicate well with investigators, understand and comply with clinical trial requirements, voluntarily participate in the study, and sign an informed consent form. Exclusion Criteria: * Participants with severe cardiovascular diseases, including but not limited to unstable angina (Canadian Cardiac Society (CCS) Grade III/IV angina pectoris), uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and/or diastolic ≥110 mmHg despite long-term regular antihypertensive medication), hypotension (resting systolic blood pressure \<90 mmHg), acute myocardial infarction, second or third-degree atrioventricular block, sinoatrial node disease, NYHA Class III/IV heart failure, dilated or hypertrophic cardiomyopathy, pericarditis, valvular heart disease, aortic dissection, uncontrolled severe arrhythmias, congenital heart disease, those who have undergone coronary artery bypass grafting or interventional procedures within three months, and those determined unsuitable for participation in this study by investigators; * Participants with severe acute or chronic pulmonary diseases (including but not limited to COPD, asthma, bronchiectasis, emphysema, pulmonary fibrosis, pulmonary embolism, pneumonia, etc.) who are determined unsuitable for participation by the investigator; * Participants with severe or unstable central nervous system disorders (including but not limited to unstable cerebrovascular diseases, active epilepsy, CNS infections, CNS diseases accompanied by mental disorders or motor impairments) who are determined unsuitable for participation by the investigator; * Participants with severe bleeding disorders or coagulation dysfunction (including but not limited to purpura, hemophilia, vitamin K deficiency, etc.) who are determined unsuitable for participation by the investigator; * Participants with severe liver dysfunction (including but not limited to viral hepatitis, autoimmune hepatitis, cirrhosis, liver cancer, etc.) who are determined unsuitable for participation by the investigator; * Participants with severe kidney impairment (including but not limited to glomerulonephritis, renal insufficiency, nephrotic syndrome, membranous nephropathy, hydronephrosis, renal cystopathy, etc.) who are determined unsuitable for participation by the investigator; * Participants with fever or active infectious diseases who are determined unsuitable for participation by the investigator; * Participants with known alcohol allergy who are determined unsuitable for participation by the investigator; * participants with known adenosine allergy who are determined unsuitable for participation by the investigator; * Participants with known iodine contrast agent allergy who are determined unsuitable for participation by the investigator; * Within the past 10 years, significant occupational exposure to ionizing radiation (e.g., exceeding 50 mSv/year) or exposure to radioactive substances or ionizing radiation for therapeutic/research purposes; * Male or women of childbearing age not using effective contraception during study participation and within 6 months post-study (effective contraception refers to sterilization, intrauterine device, condoms, abstinence, or surgical blockage of vas deferens/fallopian tubes); * Female participants in pregnancy or lactation * Individuals with claustrophobia, bipolar disorder, mental disorders, or poor compliance; * Participation in other investigational drug trials within 30 days prior to enrollment or planned during study; * Any other circumstances determined unsuitable by investigators.
Where it's running
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Beijing Anzhen Hospital, Capital Medical University
Beijing, China Recruiting -
Beijing Tongren Hospital
Beijing, China Recruiting -
Peking Union Medical College Hospital
Beijing, China Recruiting -
The First People's Hospital of Foshan
Foshan, China Recruiting -
TEDA International Cardiovascular Hospital
Tianjin, China Recruiting
Study contacts
- Study coordinator: Ling Yuan
- Email: ling.yuan@sinotau.com
- Phone: 010-80716990
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.