OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
NCT ID: NCT03180307
Last Updated: 2022-02-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
140 participants
INTERVENTIONAL
2018-01-26
2020-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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no fluorescent imaging
Patient injected with OTL38, but does not undergo fluorescent imaging
OTL38
0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes
laparotomy
primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
near infrared imaging arm
Patient injected with OTL38 and undergoes near infrared imaging
OTL38
0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes
near infrared camera imaging system
Infrared imaging used to excite OTL38 for fluorescence
laparotomy
primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
Interventions
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OTL38
0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes
near infrared camera imaging system
Infrared imaging used to excite OTL38 for fluorescence
laparotomy
primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 preoperatively 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
18 Years
85 Years
FEMALE
No
Sponsors
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SynteractHCR
INDUSTRY
On Target Laboratories, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janos Tanyi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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The Mayo Clinic - Phoenix
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
University of CA at Irvine Chao Cancer Center
Orange, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Karmanos Cancer Institutes
Detroit, Michigan, United States
Mayo Clinic-Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Kettering Medical Center
Kettering, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Leiden University Medical Center
Leiden, South Holland, Netherlands
Countries
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References
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Tanyi JL, Randall LM, Chambers SK, Butler KA, Winer IS, Langstraat CL, Han ES, Vahrmeijer AL, Chon HS, Morgan MA, Powell MA, Tseng JH, Lopez AS, Wenham RM. A Phase III Study of Pafolacianine Injection (OTL38) for Intraoperative Imaging of Folate Receptor-Positive Ovarian Cancer (Study 006). J Clin Oncol. 2023 Jan 10;41(2):276-284. doi: 10.1200/JCO.22.00291. Epub 2022 Sep 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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OTL-2016-OTL38-006
Identifier Type: -
Identifier Source: org_study_id
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