Intraoperative near-infrared fluorescence imaging of endometriosis with OTL38: a pilot study

Phase 1

• Conditions: Endometriosis; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2018-003693-27-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-31
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 15

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

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 clinical trial of medicinal product
• Study Design: Not specified