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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Female patients 18 years of age and older.
  • 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 surgery, and:
  • Who are scheduled to undergo laparotomy for the debulking surgery; or
  • Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery if cancer is detected on the laparoscopy.
  • A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential.
  • Female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion.
  • Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments.

Exclusion Criteria:

  • Previous exposure to OTL38.
  • Known FR-negative ovarian cancer.
  • Planned surgical debulking via laparoscopy or robotic surgery, with no intent of laparotomy.
  • Patients with known ovarian cancer miliary disease determined pre-operatively to be inoperable.
  • Any medical condition that, in the opinion of the investigators, could potentially jeopardize the safety of the patient.
  • History of anaphylactic reactions.
  • History of allergy to any of the components of OTL38, including folic acid.
  • Pregnancy or positive pregnancy test.
  • Clinically significant abnormalities on electrocardiogram (ECG).
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Impaired renal function defined as eGFR< 50 mL/min/1.73m2.
  • Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin.
  • Known Stage IV ovarian cancer with brain metastases.
  • Received an investigational agent in another clinical trial within 30 days prior to surgery.
  • Known sensitivity to fluorescent light.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Carrie Langstraat, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Kristina Butler, M.D., M.S.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20421998

Mayo Clinic Footer