No registrations found.
ID
Source
Brief title
Health condition
Ovarian cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Proportion of patients with at least one evaluable FR+ ovarian cancer lesion confirmed by central pathology (Standard of truth) that was detected using the combination of OTL38 and fluorescent light but not under normal light or palpation. All evaluable FR+ ovarian cancer lesions that were identified prior to or after surgery, that were detected using the combination of OTL38 and fluorescent light but not under normal light or palpation, and were removed based on the evaluation under fluorescent light, will be included in the calculation of the proportion of patients with at least one FR+ ovarian cancer lesion confirmed by central pathology. The primary endpoint will be determined based on evaluable lesions as described below.
• Evaluable lesions are defined as follows: lesions that do not appear on an organ or tissue that was intended for removal based on the Pre-Fluorescence Surgical Plan, regardless of the absence or presence of tumor.
Secondary outcome
• False Positive Rate at the patient level (FPRp) will be a major secondary efficacy endpoint and is defined as the proportion of folate positive ovarian cancer patients in whom all lesions, without regard to evaluable lesion status, detected by fluorescent light only are histologically negative. Sensitivity or True Positive Rate (TPR) for OTL38 in combination with fluorescent light, defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and ovarian cancer by central pathology relative to the total number of lesions confirmed to be FR+ and ovarian cancer by central pathology without regard to evaluable lesion status. From the classification table below: TP/TP+FN
• False positive rate (FPR) for OTL38 in combination with fluorescent light, for the purpose of this protocol, will be calculated as 1 – the Positive Predictive Value (PPV) and is defined as the proportion of fluorescent light positive lesions removed that are histologically confirmed to be non-cancerous, or if cancerous, not FR+ and ovarian cancer, by central pathology relative to the total number of lesions removed with fluorescent light imaging without regard to evaluable lesion status. From the classification table below: FP/TP+FP.
Background summary
Ovarian cancer is the twelfth leading cause of cancer death in the United States. Based on data from SEER 18 2006-2012, the overall five-year survival rate is 46.2% and for distant and unstaged disease it is only 24-28% (SEER 2016; Kosary 2007). The standard management of primary ovarian cancer is optimal cytoreductive surgery (usually defined as reduction of residual disease to less than 1 to 2 cm) followed by chemotherapy (Al Rawahi 2013). Experts are advocating complete cytoreductive surgery for tumor debulking as it results in better overall
survival than optimal cytoreduction (Shih 2010). Although tumor debulking surgery is the cornerstone of current treatment in patients, the lesions can be diffuse and numerous, of various sizes, and often not readily visible in the surgical field, leading to varying rates of optimal cytoreduction among surgeons (Ibeanu 2010). This is an
important factor in the poor prognosis for patients with advanced ovarian cancer. Tumor-specific intraoperative fluorescence imaging may improve staging and debulking efforts in cytoreductive surgery.
Study objective
Ovarian cancer is the twelfth leading cause of cancer death in the United States. Based on data from SEER 18 2006-2012, the overall five-year survival rate is 46.2% and for distant and unstaged disease it is only 24-28% (SEER 2016; Kosary 2007). The standard management of primary ovarian cancer is optimal cytoreductive surgery (usually defined as reduction of residual disease to less than 1 to 2 cm) followed by chemotherapy (Al Rawahi 2013). Experts are advocating complete cytoreductive surgery for tumor debulking as it results in better overall
survival than optimal cytoreduction (Shih 2010). Although tumor debulking surgery is the cornerstone of current treatment in patients, the lesions can be diffuse and numerous, of various sizes, and often not readily visible in the surgical field, leading to varying rates of optimal cytoreduction among surgeons (Ibeanu 2010). This is an important factor in the poor prognosis for patients with advanced ovarian cancer. Tumor-specific intraoperative fluorescence imaging may improve staging and debulking efforts in cytoreductive surgery.
Study design
Day 1, Day 7 (± 4) and Day 28 (± 4)
Intervention
Administration of OTL38 and use of a fluorescent imaging system during surgery
Inclusion criteria
1. Female patients 18 years of age and older
2. 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:
o Who are scheduled to undergo laparotomy for the debulking surgery OR
o Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery if cancer is detected on the laparoscopy
3. 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.
4. 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
5. 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
1. Previous exposure to OTL38
2. Known FR-negative ovarian cancer
3. Planned surgical debulking via laparoscopy or robotic surgery, with no intent of laparotomy.
4. Patients with known ovarian cancer miliary disease prior to surgery
5. Any medical condition that, in the opinion of the investigators, could potentially jeopardize the safety of the
patient
6. History of anaphylactic reactions
7. History of allergy to any of the components of OTL38, including folic acid
8. Pregnancy or positive pregnancy test
9. Clinically significant abnormalities on electrocardiogram (ECG)
10.Presence of any psychological, familial, sociological or geographical condition potentially hampering
compliance with the study protocol and follow-up schedule
11.Impaired renal function defined as eGFR< 50 mL/min/1.73m2
12.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.
13.Known Stage IV ovarian cancer with brain metastases
14.Received an investigational agent in another clinical trial within 30 days prior to surgery
15.Known sensitivity to fluorescent light
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7675 |
| CCMO | NL68086.056.18 |
| OMON | NL-OMON48066 |