Intraoperative near-infrared fluorescence imaging of endometriosis with OTL38: a pilot study
- Conditions
- 10029903Endometriosis
- Registration Number
- NL-OMON48378
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- 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
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
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
- Secondary Outcome Measures
Name Time Method