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Clinical Trials/NCT03793322
NCT03793322
Unknown
Phase 1

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

Zhujiang Hospital1 site in 1 country100 target enrollmentJanuary 1, 2017

Overview

Phase
Phase 1
Intervention
Indocyanine-Green(ICG)
Conditions
Hepatocellular Carcinoma
Sponsor
Zhujiang Hospital
Enrollment
100
Locations
1
Primary Endpoint
The accuracy of detecting small liver tumor by ICG fluorescence.
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
December 31, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Zhujiang Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Indocyanine-Green(ICG) injection group

Intervention: Indocyanine-Green(ICG)

Outcomes

Primary Outcomes

The accuracy of detecting small liver tumor by ICG fluorescence.

Time Frame: 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.

Time Frame: 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.

Study Sites (1)

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