Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT01383135
Status:
COMPLETED
Last Update Posted:
2024-01-12
First Post:
2011-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
Status:
COMPLETED
Status Verified Date:
2023-04
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:
The purpose of the study was to conduct a pilot test of new tracers (\[18F\]FPRGD2 and \[18F\]FPPRGD2) to define normal tracer biodistribution (where the tracer goes), stability (how much metabolises), pharmacokinetics (how much stays in which organs and for how long), and radiation dosimetry (organ radiation dose). Healthy volunteers provided the normal biodistribution data.
The same radiopharmaceutical was also tested in breast cancer, glioblastoma multiform (brain cancer), and lung cancer.
The same radiopharmaceutical was also tested in breast cancer, glioblastoma multiform (brain cancer), and lung cancer.
Detailed Description:
The tracer \[18F\]FPRGD2 was not evaluated in this study. The protocol title was never amended to reflect this.
Study Oversight
Has Oversight DMC:
True
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?: