The Application of Indocyanine-Green(ICG) Fluorescence Imaging in Hepatocellular Carcinoma

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03793322

Enrollment

100

Registered

2019-01-04

Start date

2017-01-01

Completion date

2020-12-31

Last updated

2019-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, Indocyanine-Green(ICG)

Brief summary

This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence imaging in the detection of liver tumors. By correlating the ICG fluorescence patterns with pathologically confirmed tumors , it would be possible to use fluorescence navigation system in helping promoting oncology treatment.

Interventions

DRUGIndocyanine-Green(ICG)

ICG was administered intravenously 24 hours before the operation , or directly into the portal vein branches supplying the tumor-bearing hepatic segment, after puncturing of the target segments under intraoperative ultrasonography guidance.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 18 years≤ Age ≤70 years * Compling with the diagnosis criteria of hepatic carcinoma. * Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled. * Preoperative liver function is Child - Pugh grade A or B. * The patients are volunteered for the study.

Exclusion criteria

* Patients with mental illness. * Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc. * The patients refused to take part in the study. * There are other co-existed malignant tumors. * Benign liver diseases. * Indocyanine green allergy

Design outcomes

Primary

Measure	Time frame	Description
The accuracy of detecting small liver tumor by ICG fluorescence.	3 Days	The tumor which aggregate ICG fluorescence will be resected and dignosed by pathology. The accuracy of detecting small liver tumor by ICG fluorescence will be evaluated.
The accuracy of positive margins of resection detected by ICG fluorescence.	3 Days	The surgery margins will be detected by ICG fluorescence. If there is fluorescence aggregating, we consider the presence of residual tumor in the margin and proven by histological examination.

Countries

China

Contacts

Primary ContactChihua Fang, MD; PHD

fangch_dr@126.com+8613609700805

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026