NCT05808140

Fluorescence Imaging With Indocyanine Green(ICG) in Endoscopic Spinal Surgery

Completed Phase 1, PHASE2 Last updated 19 December 2025

What this trial tests

Phase 1, PHASE2 trial testing Indocyanine Green in Disc Herniation in 40 participants. Completed in 14 December 2025.

Timeline

11 April 2023

Primary endpoint
14 December 2025

14 December 2025

Quick facts

Lead sponsor	Zhongnan Hospital
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	40
Start date	11 April 2023
Primary completion	14 December 2025
Estimated completion	14 December 2025
Sites	1 location across China

Drugs / interventions tested

• Indocyanine Green (INDOCYANINE GREEN) — full drug profile →
• Fluorescence imaging

Conditions studied

• Disc Herniation — all drugs for Disc Herniation →

Sponsor

Zhongnan Hospital

Who can join

Adults 20 to 60, any sex, with Disc Herniation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In endoscopic spinal nerve root decompression surgery, the intraoperative nerve exploration is time-consuming and critical. According to statistics, the incidence of nerve root injury under spinal endoscope is 1.8-2.5%. Damage to nerve roots may lead to postoperative sensory retardation and motor weakness, thereby impairing the physical function of patients. A real-time auxiliary intraoperative nerve identification technology is necessary.

In this prospective, open-label, randomized, parallel controlled trial, 40 patients who undergo endoscopic spinal surgery are included. Subjects are randomly divided into control group and low, medium and high Indocyanine green(ICG) preoperative administration experimental group. Standard endoscopic spinal surgery is performed in the control group. Patients in the experimental group received an intravenous injection of ICG before surgery, and a standard endoscopic spinal surgery is performed with the use of a fluoroscopic endoscopic surgical imaging system to assist the surgeon in identifying and protecting the nerve roots.

The main objectives of this experiment are (i) to explore the safety and feasibility of ICG fluorescence imaging to assist in nerve root identification during endoscopic spinal surgery and (ii) the effectiveness of this technique for endoscopic search for nerve roots. The secondary objective is to explore the optimal ICG dosing regimen.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intraoperative fluorescence redefining neurosurgical precision.
   Regmi M, Li Y, Wang Y, Liu W, et al · · 2025 · cited 7× · PMID 38913424 · DOI 10.1097/js9.0000000000001847
2. Near-Infrared Fluorescence Imaging With Indocyanine Green for Intraoperative Nerve Root Visualization in Spinal Surgery: From Preclinical Studies to a Pilot Randomized Controlled Trial.
   Huang H, Chen Z, Wu S, Wang L, et al · · 2025 · PMID 41424186 · DOI 10.1177/21925682251407941