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.
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: January 1, 2020
- 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.
Arms, Groups and Cohorts
- Experimental: Indocyanine-Green(ICG) injection group
Clinical Trial Outcome Measures
- 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.
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Zhujiang Hospital
- Provider of Information About this Clinical Study
- Overall Official(s)
- Chihua Fang, Principal Investigator, China, Guangdong Zhujiang Hospital of The Southern Medical University
- Overall Contact(s)
- Chihua Fang, MD; PHD, +8613609700805, email@example.com
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