Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05885854
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2022-12-25
Brief Title:
XTR003 PET Radiotracer for the Detection of Viable Myocardium
Sponsor:
Sinotau Pharmaceutical Group
Organization:
Sinotau Pharmaceutical Group
Study Overview
Official Title:
Exploratory Application of XTR003 as a Novel PET Myocardial Fatty Acid Metabolism Imaging Agent for the Detection of Viable Myocardium
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study was designed to explore the clinical feasibility of XTR003 a PET myocardial fatty-acid tracer for the detection of viable myocardium in patients with ischemic heart disease IHD
Detailed Description:
The incidence of IHD is increasing in China and globally However the 18F-FDG-PET patient preparation protocols present challenges in certain patients such as patients with type I and II Diabetes Mellitus XTR003 is a PET fatty-acid analog used in the imaging of myocardial fatty-acid metabolism The combination of fasting XTR00318F-FDG PET imaging may overcome the shortness of glucose-loaded 18F-FDG PET imaging protocol and effectively identify viable myocardium
This is an exploratory single-arm open-label phase II clinical study with the following objectives
1 To explore the clinical feasibility of XTR003 for the detection of viable myocardium in patients with NSTEMI old myocardial infarction or total occlusions of coronary arteries
2 To evaluate the safety and adverse events incidence of XTR003 in patients with known IHD
3 To evaluate the sensitivity and specificity of fasting 18F-FDGXTR003 PET combining imaging in detecting viable myocardium
This is an exploratory single-arm open-label phase II clinical study with the following objectives
1 To explore the clinical feasibility of XTR003 for the detection of viable myocardium in patients with NSTEMI old myocardial infarction or total occlusions of coronary arteries
2 To evaluate the safety and adverse events incidence of XTR003 in patients with known IHD
3 To evaluate the sensitivity and specificity of fasting 18F-FDGXTR003 PET combining imaging in detecting viable myocardium
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None