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

NCT07187895 | Terminated Phase 2

• 1 other identifier: STB-XTR004-202
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myocardial Perfusion Imaging; Diagnostic Certainty; Stable Coronary Artery Disease

Keywords

XTR004; MPI; PET; SPECT; diagnostic certainty

Outcome Measures

Primary Outcomes (1)

• Percentage of vessel-level diagnostic certainty for XTR004 PET/MIBI SPECT myocardial perfusion imaging.

  Day1-7

Study Arms (1)

XTR004 MPI PET & MIBI SPECT MPI

EXPERIMENTAL

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

Drug: XTR004

Interventions

XTR004 DRUG

At rest: IV bolus injection of XTR004 with a dose range of 2.0-2.5 mCi At stress: IV infusion of adenosine at a rate of 140 μg/kg/min. IV bolus injection of XTR004 with a dose range of 6.0-7.5 mCi.

XTR004 MPI PET & MIBI SPECT MPI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged 18 years or older.
• 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.
• Underwent coronary CTA within the past 6 months showing 30%-90% stenosis, or indicating mild to moderate-to-severe stenosis.
• 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.

You may not qualify if:

• \. Patients with a history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
• Patients with a prior diagnosis of myocardial infarction, congenital heart disease, cardiomyopathy, myocarditis, or other cardiac diseases.
• Patients known to have severe allergic reactions to alcohol.
• Patients known to have an allergy or other contraindications to adenosine.
• Patients known to be allergic to iodinated contrast agents.
• 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.
• 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).
• Pregnant or lactating women.
• Patients with claustrophobia, bipolar disorder, other psychiatric disorders, or poor compliance.
• Patients who participated in another investigational drug clinical study within 30 days prior to enrollment or plan to do so during follow-up.
• Any other condition that, in the opinion of the investigators, makes the patient unsuitable for participation.

Sponsors & Collaborators

• Sinotau Pharmaceutical Group: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100176, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: December 19, 2024
• Primary Completion: March 5, 2025
• Study Completion: March 5, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)