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

eiden University Medical Center0 个研究点目标入组 15 人开始时间: 2019年1月31日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•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

•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

发起方

eiden University Medical Center