Endometriosis
Conditions
Interventions
Product Name: OTL38
Product Code: OTL38
Pharmaceutical Form: Solution for injection
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female (premenopausal) patients 18 years of age and older 2. Patients scheduled for elective surgery (laparoscopic or laparotomy) for the diagnosis or treatment of endometriosis 3. WHO performance score of 0-2 4. A negative serum pregnancy test at screening followed by a negative serum pregnancy test on the day of surgery or day of admission for female patients of childbearing potential 5. Female patients of childbearing potential agree to use an acceptable form of contraception from the time of signing informed consent until 90 days after study completion 6. Ability to understand the requirements of the study, provide written informed consent 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous exposure to OTL38 2. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient 3. History of anaphylactic reactions 4. History of allergy to any of the components of OTL38, including folic acid 5. Pregnancy (or positive pregnancy test) or breast-feeding 6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 7. Impaired renal function defined as eGFR 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin 9. Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to surgery 10. Known sensitivity to fluorescent light
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: - To assess the feasibility of a single intravenous injection of OTL38 in detecting endometriosis during surgery by determining the concordance between fluorescent signal and histopathological confirmed endometriotic tissue. - To assess the safety and tolerability of single intravenous dose of OTL38. ;Secondary Objective: Secondary objective: - Localization of occult endometriotic lesions with NIR imaging and OTL38, that would otherwise remain invisible with white light only. ;Timepoint(s) of evaluation of this end point: End of the study;Primary end point(s): Primary endpoint: - To determine the sensitivity or true positive rate (TPR) for OTL38 in combination with NIR fluorescence imaging, defined as the proportion of fluorescent positive tissue samples (of resected tissue or biopsies) that are histologically confirmed endometriotic tissue and FR+ relative to the total number of tissue samples confirmed to be FR+ and endometriotic tissue. Sensitivity = (True Positive)/(True Positive +False Negative). - 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 positive tissue samples removed (of resected tissue or biopsies) that are histologically confirmed to be non-endometriotic tissue by the pathologist relative to the total number of tissue samples removed with fluorescent light imaging. False Positive Rate = (False Positives) / (True Positives + False Positives). - Incidence rates of all treatment-emergent AEs (TEAEs), adverse device effects (ADEs), and SAEs, from the time of OTL38 administration until follow-up visit 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: End of the study;Secondary end point(s): Secondary endpoint: - The proportion of lesions identification with OTL-38 and NIR that could not otherwise be identified by white light and finger palpation. | — |
Countries
Netherlands
Contacts
Public ContactAlexander Vahrmeijer
Leiden University Medical Center
Outcome results
None listed