NCT05885841

Evaluation of XTR004 as a Novel 18F-labeled PET MPI Tracer in Diagnosis of Known or Suspected CAD

Evaluation of XTR004 as a Novel 18F-labeled PET Myocardial Perfusion Imaging (MPI) Tracer in Diagnosis of Known or Suspected CAD Compared With Invasive Coronary Angiography, Fractional Flow Reserve, Index of Microcirculatory Resistance

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Sinotau Pharmaceutical Group · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The diagnostic efficacy and safety of the XTR004 myocardial perfusion PET imaging tracer are evaluated for known or suspected CAD with the use of invasive coronary angiography as the reference standard for the diagnosis of CAD and invasive pressure-temperature FFR/IMR as a reference for the detection of abnormal coronary function.

Detailed description

A phase II study that is single-arm, open-label, multi-center, and self-controlled with the following objectives; 1. Quantitative diagnostic efficacy of XTR004 perfusion imaging tracer in the diagnosis of known or suspected CAD using invasive coronary angiography as a reference standard for CAD. 2. The effectiveness of XTR004 myocardial perfusion imaging tracer in the detection of CAD using a pressure-temperature guide wire fractional flow reserve (FFR), and index of microcirculation resistance (IMR) as a reference standard to confirm abnormal coronary blood flow reserve and microvascular disfunction. 3. Subjects' safety after two doses of XTR004 intravenous injection.

Conditions

• Coronary Artery Disease (CAD)

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: 2022-02-15
• Primary completion: 2023-05-09
• Completion: 2023-05-09
• First posted: 2023-06-02
• Last updated: 2023-06-02

Locations

2 sites across 1 country: China