Intraoperative near-infrared fluorescence imaging of endometriosis with OTL38: a pilot study
- Conditions
- Endometriosis
- Registration Number
- NL-OMON28293
- Lead Sponsor
- MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
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
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< 50 mL/min/1.73m2
8.Impaired liver function defined as values > 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -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.<br>-To assess the safety and tolerability of single intravenous dose of OTL38.<br>
- Secondary Outcome Measures
Name Time Method -Localization of occult endometriotic lesions with NIR imaging and OTL38, that would otherwise remain invisible with white light only.