Comparison of Diagnostic Accuracy Between XTR004 PET MPI and the Composite Index of Quantitative Coronary Angiography (QCA) and Fractional Flow Reserve (FFR)

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

The primary objective of this study is to evaluate the effectiveness of visual reading in XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards in patients with suspected or known coronary artery disease.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease(CAD)
• Intervention / Treatment: Drug: XTR004

• Study Type: Interventional
• Enrollment (Estimated): 395
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: LING YUAN; Phone Number: 010-80716990; Email: ling.yuan@sinotau.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital
  • Beijing, China
    • Recruiting
    • Beijing Anzhen Hospital, Capital Medical University
  • Beijing, China
    • Recruiting
    • Beijing Tongren Hospital
  • Foshan, China
    • Recruiting
    • The First People's Hospital of Foshan
  • Tianjin, China
    • Recruiting
    • Teda International Cardiovascular Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: enrolled participants with suspected or known CAD	Drug: XTR004; XTR004 as the experiemental drug, 99mTechnetium Sestamibi as the Active Comparator, and Coronary artery angiography as the refenrece standard; Other Names: Drug: 99mTechnicium Sestamibi; Procedure: Coronary angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Efficacy of XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards	Sensitivity and specificity of XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the differences in diagnostic efficacy between XTR004 PET MPI and MIBI SPECT MPI in detecting restrictive stenosis	Sensitivity and specificity of XTR004 PET MPI and MIBI SPECT MPI in detecting restrictive stenosis	60 days
To assess differences in image quality and diagnostic certainty between XTR004 PET MPI and MIBI SPECT MPI	Overall summary of image quality and diagnostic certainty of XTR004 PET MPI and MIBI SPECT MPI	60 days
To validate the effectiveness of semi-quantitative analysis in XTR004 PET MPI for the detection of restrictive stenosis	Overall summary of the sensitivity and specificity of semi-quantitative analysis in XTR004 PET MPI for the detection of restrictive stenosis	60 days
To evaluate the diagnostic efficacy of XTR004 PET MPI in different subgroups	Sensitivity and specificcity of XTR004 PET MPI in detection of flow-limiting stenosis in different subgroups, including subjects with different stenosis degrees detected by CTA, female, BMI ≥30kg/m2, and subjects with diabetes	60 days
To compare the differences in diagnostic performance between XTR004 PET MPI and MIBI SPECT MPI using QCA results as a reference standard	Overall summary of diagnostic efficacy of XTR004 PET MPI and MIBI SPECT MPI using QCA results as a reference standard	60 days
Number of participants with treatment-related adverse events, severe adverse events as assessed by CTCAE v5.0	To assess the safety in subjects with suspected or confirmed stable coronary artery disease after two consecutive intravenous bolus injections of XTR004 solution	60 days

Collaborators and Investigators

• Sponsor: Sinotau Pharmaceutical Group

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: STB-XTR004-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No