NCT03180307

OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer

A Phase 3, Randomized, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: On Target Laboratories, LLC · Industry
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.

Detailed description

The Phase 3 study is to confirm the efficacy of OTL38 in combination with fluorescent light to detect additional Folate Receptor-positive (FR+) ovarian cancer lesions not detected by palpation and visualization under normal light in patients with FR+ ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	OTL38	0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes
DEVICE	near infrared camera imaging system	Infrared imaging used to excite OTL38 for fluorescence
PROCEDURE	laparotomy	primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

Timeline

• Start date: 2018-01-26
• Primary completion: 2020-04-16
• Completion: 2020-10-16
• First posted: 2017-06-08
• Last updated: 2022-02-04
• Results posted: 2022-02-04

Locations

11 sites across 2 countries: United States, Netherlands

Regulatory

• FDA-regulated drug study
• FDA-regulated device study