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

Phase 1/2 Completed 41 enrolled Li-Cor, Inc.

SequentialOpen-labelDiagnostic

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.

Timeline

Start: 2017-04-26
Primary completion: 2018-11-19
Completion: 2018-11-19

Publications

Huh WK, Johnson JL, Elliott E, Boone JD, Leath CA 3rd, Kovar JL, Kim KH. Fluorescence Imaging of the Ureter in Minimally Invasive Pelvic Surgery. J Minim Invasive Gynecol. 2021 Feb;28(2):332-341.e14. doi: 10.1016/j.jmig.2020.06.022. Epub 2020 Jun 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nerindocianine	Diagnostic / imaging agent	0.045 mg/kg	Intravenous
Subject	Nerindocianine	Diagnostic / imaging agent	0.06 mg/kg	Intravenous
Subject	Nerindocianine	Diagnostic / imaging agent	0.12 mg/kg	Intravenous

Indications

No indication recorded.