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

NCT03793322 | Unknown Phase 1

• 1 other identifier: 201803
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Indocyanine-Green(ICG)

Outcome Measures

Primary Outcomes (2)

• The accuracy of detecting small liver tumor by ICG fluorescence.

  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.

  3 Days

• The accuracy of positive margins of resection detected by ICG fluorescence.

  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.

  3 Days

Study Arms (1)

Indocyanine-Green(ICG) injection group

EXPERIMENTAL

Drug: Indocyanine-Green(ICG)

Interventions

Indocyanine-Green(ICG) DRUG

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.

Indocyanine-Green(ICG) injection group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Chihua Fang

  China, Guangdong Zhujiang Hospital of The Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chihua Fang, MD; PHD

CONTACT

+8613609700805; fangch_dr@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 4, 2019
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: December 31, 2020
• Last Updated: January 4, 2019

Record last verified: 2017-01

Locations

CN (1)