Ignite Creation Date:
2024-05-06 @ 12:53 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01681524
Status:
WITHDRAWN
Last Update Posted:
2013-05-30
First Post:
2012-08-28
Brief Title:
Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI
Sponsor:
Lantheus Medical Imaging
Organization:
Lantheus Medical Imaging
Study Overview
Official Title:
A Phase 3 Open Label Multicenter Study for the Assessment of Myocardial Perfusion Using Positron Emission Tomography PET Imaging of Flurpiridaz F18 Injection in Patients With Suspected or Known Coronary Artery Disease CAD
Status:
WITHDRAWN
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
delayed study start
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to determine if the study drug in PET imaging is better than SPECT imaging currently used for this purpose
Detailed Description:
The study will assess the diagnostic efficacy sensitivity and specificity of Flurpiridaz F18 Injection MPI in comparison with SPECT MPI in patients with known or suspected CAD Six hundred and seventy-two evaluable patients will be enrolled and will undergo SPECT MPI and Flurpiridaz F18 PET MPI Patients will be considered for enrollment if they are scheduled to undergo or have undergone prior ICA without intervention being either positive or negative for CAD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None