Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2025-12-29 @ 9:08 PM
Study NCT ID:
NCT07187895
Status:
TERMINATED
Last Update Posted:
2025-09-23
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Imaging of XTR004 PET and MIBI SPECT in Borderline Coronary Stenosis
Sponsor:
Sinotau Pharmaceutical Group
Organization:
Study Overview
Official Title:
Comparative Imaging Study of PET Myocardial Perfusion With XTR004 Injection Versus MIBI SPECT in Patients With Borderline Coronary Stenosis
Status:
TERMINATED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The main objective of this study has been achieved. Following internal discussions, the sponsor has decided to terminate this study early.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
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?: