drugset / Trial / NCT05885841
Evaluation of XTR004 as a Novel 18F-labeled PET MPI Tracer in Diagnosis of Known or Suspected CAD
NaSingle-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2022-02-15
- Primary completion
- 2023-05-09
- Completion
- 2023-05-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | XTR004 | Diagnostic / imaging agent | 2 mbq | Intravenous |
| Subject | XTR004 | Diagnostic / imaging agent | 2.5 mbq | Intravenous |
| Subject | XTR004 | Diagnostic / imaging agent | 6 mbq | Intravenous |
| Subject | XTR004 | Diagnostic / imaging agent | 7.5 mbq | Intravenous |
| Background | Adenosine | Small molecule | 140 ug/kg | Intravenous |