Ignite Creation Date:
2024-05-05 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00733460
Status:
COMPLETED
Last Update Posted:
2013-06-10
First Post:
2008-08-12
Brief Title:
A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion ImagingMPI Agent for PET
Sponsor:
Fluoropharma Inc
Organization:
Fluoropharma Inc
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety Biodistribution and Radiation Dosimetry of BFPET as a Potential Myocardial Perfusion Imaging MPI Agent for PET
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Safety and dosimetry of BFPET will be evaluated in healthy volunteers and Coronary Artery Disease CAD patients male or female and of age ranging between 20-80 years old
Detailed Description:
Study Procedures
Visit 1 Screening - Eligibility determination
Visit 2 within 14 days post screening Injection of BFPET and PET Imaging
Visit 3 within 24-48 hours post dose Follow-up Visit
Visit 1 Screening - Eligibility determination
Visit 2 within 14 days post screening Injection of BFPET and PET Imaging
Visit 3 within 24-48 hours post dose Follow-up Visit
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