Delving into the Latest Updates on Nerindocianine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Irdye 800Bk, Nerindocianine Sodium, 橙花碱

Target-

Mechanism-

Therapeutic Areas

Urogenital Diseases

Active Indication-

Inactive Indication

Ureteral Diseases

Originator Organization-

Active Organization-

Inactive Organization

LI-COR, Inc.

Drug Highest PhasePendingPhase 1/2

First Approval Date-

Regulation-

Login to view timeline

Structure

Molecular FormulaC44H52N2Na4O16S5

InChIKeyWVYTXEDXBIOYBA-UHFFFAOYSA-N

CAS Registry262284-03-7

IRDye® 800BK is a fluorophore, currently undergoing clinical translation, which has both biliary and renal clearance. To date, there is no description of a fluorophore, which can be simultaneously used for non-invasive, near-infrared fluorescence-based (NIRF) visualization of different structures and perfusion evaluation. The purpose of this study was to evaluate IRDye® 800BK for the simultaneous assessment of bowel perfusion, lymphography, ureter and bile duct delineation.

METHODS:

Six pigs received a 0.15 mg/kg dye as a single bolus intravenous injection (IV). With the FLER (fluorescence-based enhanced reality) software, fluorescence intensity (FI) of 5 regions of interest (ROI) in an ischemic bowel loop was measured along with the time to reach the FI peak, and capillary lactate was measured from the same ROI, followed by the assessment of the ureters and bile ducts for a maximal duration of 180 min after dye administration. In 3 animals, the procedure was initiated via gastroscopic injection of a 0.6 mg (1 mg/mL) dye in the gastric submucosa followed by lymphography in a NIRF setting.

RESULTS:

Excellent visualization of the ureters and bowel perfusion was obtained under NIRF imaging. Additionally, the bile duct and gastric lymph ducts and nodes were visualized. A positive correlation was found between the time to peak FI in the ischemic bowel loop and the corresponding capillary lactate levels (rho 0.59, p < 0.001).

CONCLUSION:

In this study, we successfully demonstrated the simultaneous multipurpose IRDye® 800BK applicability during laparoscopic surgery. This fluorophore has the potential to become a powerful and versatile image-guided surgery tool.

01 Feb 2021·Journal of Minimally Invasive Gynecology

Fluorescence Imaging of the Ureter in Minimally Invasive Pelvic Surgery.

Article

Author: Elliott, Emily ; Leath, Charles A ; Kim, Kenneth H ; Johnson, John L ; Huh, Warner K ; Kovar, Joy L ; Boone, Jonathan D

STUDY OBJECTIVE:

Determine near-optimal dose, safety, and efficacy of nerindocianine in pelvic ureter detection with near-infrared fluorescence imaging in women undergoing minimally invasive pelvic surgery with 3 Food and Drug Administration-cleared imaging systems.

DESIGN:

Open label, phase 1/2a study.

SETTING:

University of Alabama at Birmingham.

PATIENTS:

Forty-one female subjects undergoing minimally invasive gynecologic surgery.

INTERVENTIONS:

Subjects received a single dose of nerindocianine sodium, starting at 0.06-mg/kg body weight and increased/decreased until the near-optimal dose was determined (part A). Examine the degree of concordance between endoscopic and robotic devices (part B).

MEASUREMENTS AND MAIN RESULTS:

In part A, composite scores were collected every 10 minutes for 30 minutes and then every 15 minutes through 90 minutes using a scale measuring the anatomy/laterality of ureter visualization. In part B (paired imaging system efficacy), 2 cohorts of 8 subjects each received the near-optimal dose. Composite scores for visualization of the ureter were collected at 10 and 30 minutes postinfusion with the Firefly Imaging System and either the PINPOINT or 1588 AIM endoscope. Composite scores were compared to examine the degree of concordance between devices. Part A comprised 25 total subjects enrolled in dosing groups 1, 2, and 3 (0.06-, 0.12-, and 0.045-mg/kg, respectively). Median time to first ureter visualization was 10 minutes (all groups). The nerindocianine 0.06-mg/kg and 0.12-mg/kg groups had longer length of time of visualization than the 0.045-mg/kg group, resulting in the selection of 0.06 mg/kg as the near-optimal dose. Part B enrolled 16 total subjects in 2 groups dosed at 0.06 mg/kg. Efficacy analysis showed no statistically significant difference in composite scores with Firefly versus PINPOINT or 1588 AIM.

CONCLUSION:

Nerindocianine was well tolerated with visualization of the ureter demonstrated in 88.9% of the subjects through 90 minutes postdosing. No meaningful visualization differences were observed among the Food and Drug Administration-cleared surgical imaging systems used.

01 Sep 2020·Journal of laparoendoscopic & advanced surgical techniques. Part AQ4 · MEDICINE

The Use of IRDye 800BK for Intraoperative Ureteral Visualization: The Future of the Ureter Is Bright!

Q4 · MEDICINE

Article

Author: Diana, Michele ; Al-Taher, Mahdi

100 Deals associated with Nerindocianine

Login to view more data