Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2025-12-30 @ 7:30 PM
Study NCT ID:
NCT03073395
Status:
COMPLETED
Last Update Posted:
2025-02-26
First Post:
2017-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preliminary Evaluation of Uptake of [68Ga]P16-093 in Metastatic Prostate and Renal Cancer
Sponsor:
Five Eleven Pharma, Inc.
Organization:
Study Overview
Official Title:
Preliminary Investigation of Uptake in PSMA Expressing Cancer, Biodistribution and Excretion of the Novel Radio Tracer [68Ga]P16-093 by PET/CT
Status:
COMPLETED
Status Verified Date:
2025-02
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:
An phase I study to evaluate the uptake of \[68Ga\]P16-093 in known or suspected metastatic prostate or renal cancer to establish the feasibility of using \[68Ga\]P16-093 to image PSMA expressing cancer. Measurement of the whole body biodistribution of \[68Ga\]P16-093 in prostate cancer patients post primary curative-intent treatment with stable PSA to generate human radiation dosimetry data.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: