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

  • STATUS
    Recruiting
  • End date
    Aug 22, 2023
  • participants needed
    36
  • sponsor
    Abramson Cancer Center of the University of Pennsylvania
Updated on 22 October 2021
recurrent ovarian cancer
tumor debulking
cytoreduction
cancer of the ovary

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.

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

Details
Condition Ovarian Function, Ovarian disorder, Recurrent Ovarian Cancer, cancer ovarian, ovarian tumors, cancer of the ovary, cancer, ovarian, Ovarian Cancer, ovarian carcinomas
Treatment OTL38, intraoperative imaging camera system
Clinical Study IdentifierNCT04941378
SponsorAbramson Cancer Center of the University of Pennsylvania
Last Modified on22 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Female patients > 18 years of age
Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer
Good operative candidate as determined by clinical presentation and laboratory assessments
Subject capable of giving informed consent and participating in the process of consent

Exclusion Criteria

Pregnant women as determined by urinary or serum beta hCG
Patients with a history of allergy to any of the components of OTL38, including folic acid
Known FR-negative ovarian cancer
Patients with a known allergy to Benadryl
Previous exposure to OTL38
Vulnerable populations: the homeless, prisoners or not capable of participating in the consent process
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