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

Phase 1

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Indocyanine-Green(ICG)

• Registration Number: NCT03793322
• Lead Sponsor: Zhujiang Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01-01
• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-02
• Last Update Submitted: 2019-01-02
• Study First Posted: 2019-01-04
• Last Update Posted: 2019-01-04
• Primary Completion: 2020-01-01
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Indocyanine-Green(ICG) injection group	Indocyanine-Green(ICG)	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Zhujiang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China