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

LI-COR

Status and phase: Completed; Phase 2; Phase 1

Conditions: Intraoperative Ureter Injury

Treatments: Drug: Nerindocianine for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03106038

LICOR-10417-01

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

41 participants in 1 patient group

Nerindocianine for Injection

Experimental group

Description:

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.

Treatment:

Drug: Nerindocianine for Injection