Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-03-03 @ 6:46 PM
Study NCT ID:
NCT02317705
Status:
COMPLETED
Last Update Posted:
2022-06-21
First Post:
2014-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer
Sponsor:
On Target Laboratories, LLC
Organization:
Study Overview
Official Title:
A Phase 2, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2022-05
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 study is being done to:
* test the safety of OTL38
* see if OTL38 helps light up the cancer when viewed with the special camera system
* test the safety of the special camera system for use along with OTL38 during surgery
* test the safety of OTL38
* see if OTL38 helps light up the cancer when viewed with the special camera system
* test the safety of the special camera system for use along with OTL38 during surgery
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?:
None
Is an FDA AA801 Violation?: