NCT02317705

Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: On Target Laboratories, LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	OTL38
DEVICE	Near infrared camera imaging system	Near infrared camera imaging system
PROCEDURE	Laparotomy	primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-12-16
• Last updated: 2022-06-21
• Results posted: 2022-06-21

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study