Dose-escalation Study of a Contrast Agent for Delineation of Urological Anatomy in Minimally Invasive Surgery

Study Overview
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Brief Summary
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The purpose of this clinical trial is to study the safety and efficacy of an investigational imaging agent for delineation/visualization of urologic anatomy in the setting of minimally invasive surgery.

Official Title
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A Phase I/IIa Dose-escalation Study to Evaluate the Use of an Investigational Imaging Agent for the Detection of Urologic Anatomy Via Near Infrared Fluorescence Imaging in the Setting of Minimally Invasive Surgery

Conditions
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Intraoperative Ureter Injury

Intervention / Treatment
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* Drug: Nerindocianine for Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent prior to the initiation of study procedures Are > 18 years of age Women consented to undergo standard of care minimally invasive pelvic surgery (traditional laparoscopy and robotic surgery) Women who are expected to be admitted to the hospital following surgery for at least 24 hours Exclusion Criteria: Are unwilling or unable to provide informed consent. Are unwilling or unable to comply with the requirements of the protocol. History of prior urologic surgery. History of prior pelvic surgery. History of known retroperitoneal fibrosis. Have any of the following screening laboratory values: Hemoglobin ≤ 8.0 g/dL; Absolute neutrophil count (ANC) ≤ 1500/μL; Platelet count ≤ 100,000/μL; Serum creatinine ≥ 1.5 x the institutional upper limit of normal (IULN) creatinine; Serum bilirubin ≥ 1.5 x IULN; Aspartate transaminase (AST or serum glutamic oxaloacetic transaminase, SGOT) ≥ 2x IULN;• Alanine transaminase (ALT or serum glutamate pyruvate transaminase, SGPT) ≥ 2 x IULN. Females who are pregnant, lactating, or breastfeeding; Any other condition that, in the Investigator's judgment, would potentially compromise the study compliance or the ability to evaluate safety or efficacy.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Interventional Model Description: beginning at the estimated target dose, the dosage was increased and decreased to confirm the near-optimal dose.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nerindocianine for Injection<br>One Arm: Nerindocianine for Injection (Initial dosing cohort: 0.06 mg/kg body weight); solution, intravenous, one time administration during surgery. the study has only one arm. | Drug: Nerindocianine for Injection<br>* Procedure: routine minimally invasive pelvic surgery.<br>* Other names: IRDye 800BK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events | 30 days | 
| Dose response | Dose response based on the composite assessment of the anatomy and laterality for detection of pelvic ureter in women undergoing minimally invasive surgery | 10 minutes through 90 minutes post administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contrast agent, ureter imaging, intraoperative monitoring, intraoperative procedures, near infrared fluorescence, minimally invasive