Endometriosis
Conditions
Interventions
This is a phase 2, multicenter, single dose, open-label pilot study in endometriosis patients scheduled to undergo surgery.
Each patient will be dosed with 0.025 mg/kg OTL38 intravenously.
Sponsors
LUMC
Eligibility
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 urine 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 930 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
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 |
|---|---|
| -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
| Measure | Time frame |
|---|---|
| - Localization of occult endometriotic lesions with NIR imaging and OTL38, that would otherwise remain invisible with white light only. | — |
Contacts
Public ContactMarion Deken
Leiden University Medical Center
Outcome results
None listed