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

June 23, 2022 updated by: Abramson Cancer Center of the University of Pennsylvania

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OTL 38
The study drug in question is an Investigational New Drug (IND), folate analog ligand conjugated with an indole cyanine green-like dye called OTL38. There will be a single dose of 0.025 mg/kg for intravenous injection over approximately 60 minutes, completed at least 1 hour prior to intraoperative imaging
Drug: OTL38
One time infusion of OTL38
Device: intraoperative imaging camera system
intraoperative imaging camera system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the performance of different camera imaging systems in assessing the positive predictive values
Time Frame: Up to 4 weeks post surgery (completion of post-operative follow-up visit)
The primary objective of the study is to compare the performance of different camera imaging systems in assessing the sensitivity and positive predictive value of OTL38 to detect folate positive ovarian cancers using the gold standard of pathologic review.
Up to 4 weeks post surgery (completion of post-operative follow-up visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Sunil Singhal, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2022

Primary Completion (Actual)

May 28, 2022

Study Completion (Actual)

May 28, 2022

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

June 25, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 11818

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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