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

Intraoperative Ureter Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03106038
• Other study ID #: LICOR-10417-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 26, 2017
• Est. completion date: November 19, 2018

Study information

• Verified date: November 2019
• Source: Li-Cor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 19, 2018
• Est. primary completion date: November 19, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intraoperative Ureter Injury

Intervention

Drug:
• Nerindocianine for Injection
Procedure: routine minimally invasive pelvic surgery.

Locations

Country	Name	City	State
United States	UAB Women & Infants Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Li-Cor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-Emergent Adverse Events	Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events	30 days
Primary	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