Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04594941
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2020-09-29
Brief Title:
A Study of Flurpiridaz 18F Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes
Sponsor:
GE Healthcare
Organization:
GE Healthcare
Study Overview
Official Title:
A Descriptive Comparative Randomized Crossover Study of Flurpiridaz 18F Injection for Positron Emission Tomography PET Imaging for Assessment of Myocardial Perfusion Imaging Quality Using High Performance Liquid Chromatography HPLC and Solid Phase Extraction SPE Manufacturing Processes
Status:
COMPLETED
Status Verified Date:
2023-07
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:
This was a Phase 2 prospective randomized crossover study of Flurpiridaz 18F Injection for PET-MPI in participants referred for evaluation of known coronary artery disease CAD or for suspected CAD with intermediate to high pre-test probability PTP The objective is to assess the difference and variability between 2 sets of rest images synthesized by the same or 2 different manufacturing processes Twenty-eight evaluable participants were enrolled in this study and underwent 2 Flurpiridaz 18F Injection PET-MPI at rest Each participant attended a Screening Visit at least 2 days and up to 14 days prior to the first Flurpiridaz 18F Injection PET-MPI The participants were randomized 1111 to 4 possible sequences of receiving 2 doses of Flurpiridaz 18F Injection 2 groups of 7 participants received 2 Flurpiridaz 18F Injection doses synthesized by the same manufacturing processes either HPLC or SPE and 2 groups of 7 subjects will receive 2 Flurpiridaz 18F Injection doses synthesized by different manufacturing processes 1 dose by HPLC followed by 1 dose by SPE or 1 dose by SPE followed by 1 dose by HPLC All participants were followed up by telephone for adverse events AEs and serious AEs SAEs at 24 8 hours following each Flurpiridaz 18F Injection administration
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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