Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413647
Status:
COMPLETED
Last Update Posted:
2013-06-12
First Post:
2006-12-18
Brief Title:
A Phase I Study in Healthy Volunteers to Evaluate the Safety of CardioPET in Detection of Coronary Artery Disease
Sponsor:
Fluoropharma Inc
Organization:
Fluoropharma Inc
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety Biodistribution and Radiation Dosimetry of CardioPET as a PET Tracer for Detection of Coronary Artery Disease
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 CardioPET will be evaluated in normal healthy volunteers and CAD subjects both male and female between the ages of 50-85 Nine normal controls will undergo repeated whole body imaging for biodistribution and dosimetry estimation Six other normal healthy subjects will undergo heart imaging only Six CAD subjects will undergo heart imaging only
Detailed Description:
CardioPET is a modified fatty acid MFA that closely resembles naturally-occurring free fatty acids FFAs in the human body
Study Procedures
Visit 1 Screening - Eligibility determination
Visit 2 Injection and PET Imaging
Visit 3 Follow-up Visit
Study Procedures
Visit 1 Screening - Eligibility determination
Visit 2 Injection and PET Imaging
Visit 3 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