Back to resultsThe Application of Indocyanine-Green(ICG) Fluorescence Imaging in Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Indocyanine-Green(ICG)
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Indocyanine-Green(ICG)
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
Sites / Locations
- Zhujiang Hospital of Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Indocyanine-Green(ICG) injection group
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03793322
Brief Title
The Application of Indocyanine-Green(ICG) Fluorescence Imaging in Hepatocellular Carcinoma
Official Title
The Application of Indocyanine-Green(ICG) Fluorescence Imaging in Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, Indocyanine-Green(ICG)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Indocyanine-Green(ICG) injection group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Indocyanine-Green(ICG)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The accuracy of detecting small liver tumor by ICG fluorescence.
Description
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.
Time Frame
3 Days
Title
The accuracy of positive margins of resection detected by ICG fluorescence.
Description
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.
Time Frame
3 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chihua Fang, MD; PHD
Phone
+8613609700805
Email
fangch_dr@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chihua Fang
Organizational Affiliation
China, Guangdong Zhujiang Hospital of The Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chihua Fang, MD
Phone
(+86)2062782568
Email
s_mountain@126.com
First Name & Middle Initial & Last Name & Degree
Qingshan Chen, MM
Phone
(+86)2062782568
Email
s_mountain@126.com
12. IPD Sharing Statement
Learn more about this trial
The Application of Indocyanine-Green(ICG) Fluorescence Imaging in Hepatocellular Carcinoma
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