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

• Status: Completed
• Trial end date: 2018-11-19
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Li-Cor, Inc.

Criteria

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.