NCT07187895

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

Comparative Imaging Study of PET Myocardial Perfusion With XTR004 Injection Versus MIBI SPECT in Patients With Borderline Coronary Stenosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Sinotau Pharmaceutical Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This trial is a single-arm, single-center, open-label, self-controlled study. 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. Imaging will be independently and blindly read by expert readers for both MIBI SPECT MPI and XTR004 PET MPI. The diagnostic certainty of the reading results from the two imaging modalities will then be compared.

Conditions

• Myocardial Perfusion Imaging
• Diagnostic Certainty
• Stable Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	XTR004	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.

Timeline

• Start date: 2024-12-19
• Primary completion: 2025-03-05
• Completion: 2025-03-05
• First posted: 2025-09-23
• Last updated: 2026-01-12

Locations

1 site across 1 country: China