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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03793322
• Other study ID #: 201803
• Status: Recruiting
• Phase: Phase 1
• Start date: January 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2017
• Source: Zhujiang Hospital
• Contact: Chihua Fang, MD; PHD
• Phone: +8613609700805
• Email: fangch_dr[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Indocyanine-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.

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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