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

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

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.

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.