NCT04941378

OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer

A Pilot, Single Dose, Open-Label Study of OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to compare the performance of different camera imaging systems in assessing the positive predictive values and sensitivity of OTL38 to detect folate positive ovarian cancer cancers using the gold standard of pathologic review.

Detailed description

Patients will be seen in the Ovarian Cancer Clinic. Patients that have or are suspected to have ovarian cancer, and are candidates for debulking surgery based on the clinician evaluation, may be considered candidates for this study. As over 90% of ovarian epithelial cancers express folate receptor, we would expect a high percentage of these patients scheduled for surgery, to have eligible cancer types for entry into the study. These patients will be prospectively consented to participate in this trial. There will be no randomization or control group and only patients previously scheduled to undergo surgery will be eligible to participate. We anticipate a 2-year period will be necessary to reach our accrual goal of up to 10 patients. After obtaining informed consent, patients will receive a one-time dose of 0.025 mg/kg of OTL38, infused over approximately 60 minutes and completed at least 1 hour prior to intraoperative imaging. As a prophylactic measure, we recommend 25mg of IV Benadryl to the patient prior to the infusion of OTL38 to decrease the possibility of a hypersensitivity reaction. The duration of surgical procedures to resect ovarian cancers varies substantially, anywhere from 3- 8 hours or more. During the phase 2 study, the median time spent imaging the patients with a single camera was 14 minutes. Utilizing two cameras to complete imaging would not overly increase the duration of time patients spend under anesthesia. However, there is a chance that being under anesthesia for the additional 25-35 minutes could put the patient at an increased risk of having of a common side effect associated with anesthesia. These common side effects include, but are not limited to: nausea and vomiting after surgery, sore throat and hoarseness, shivering/chills, confusion, and muscle aches

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	OTL38	One time infusion of OTL38
DEVICE	intraoperative imaging camera system	intraoperative imaging camera system

Timeline

• Start date: 2022-05-28
• Primary completion: 2022-05-28
• Completion: 2022-05-28
• First posted: 2021-06-28
• Last updated: 2022-06-27

Locations

1 site across 1 country: United States

Regulatory

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