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

Phase 1

Completed

• Conditions: Intraoperative Ureter Injury
• Interventions: Drug: Nerindocianine for Injection

• Registration Number: NCT03106038
• Lead Sponsor: Li-Cor, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-10
• Study Start: 2017-04-26
• Primary Completion: 2018-11-19
• Study Completion: 2018-11-19
• Status Verified: 2019-11
• Disposition First Submitted: 2019-11-15
• Disposition First Submitted QC: 2019-11-15
• Disposition First Posted: 2019-11-20
• Last Update Submitted: 2019-11-22
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Nerindocianine for Injection	Nerindocianine for Injection	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

UAB Women & Infants Center; 🇺🇸 Birmingham, Alabama, United States