Using indocyanine green imaging to improve liver cancer surgery
Multicenter Randomized Controlled Clinical Trial of Indocyanine Green Molecular Fluorescence Imaging in the Diagnosis and Treatment of Primary Liver Cancer
This study is testing if a special imaging technique can help doctors remove liver tumors more accurately and improve survival for patients with early-stage liver cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 348 (estimated) |
| Ages | 18 Years to 66 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05160740 on ClinicalTrials.gov |
What this trial studies
This study explores the clinical outcomes of using indocyanine green molecular fluorescence imaging during local resection of primary hepatocellular carcinoma at CNLC stage Ia. The technique aims to enhance surgical precision and improve tumor-free survival rates. By analyzing data from over 1000 liver resection procedures, the researchers will assess the efficacy of this cost-effective and radiation-free imaging method in guiding surgical interventions. The study is designed to provide valuable insights into the potential benefits of this imaging technology in liver cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-66 with a first clinical diagnosis of primary liver cancer at CNLC stage Ia and Child-Pugh liver function grades A or B.
Not a fit: Patients with severe comorbidities that prevent surgery, advanced liver cancer with metastasis, or those with Child-Pugh grade C liver function are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and survival rates for patients with primary liver cancer.
How similar studies have performed: While this specific application of indocyanine green imaging is novel, similar imaging techniques have shown promise in enhancing surgical outcomes in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * First clinical diagnosis of primary liver cancer (China liver cancer staging, CNLC Ia stage); * Child-Pugh grading standard of liver function was GRADE A or B; * 18-66 years old; * Complete clinical case data; * limited surgical methods (local resection); * Voluntarily participate in the study and sign the informed consent. Exclusion Criteria: * There are basic diseases that cannot tolerate surgery (such as severe cardiopulmonary cerebral renal insufficiency); * Tumor thrombus or distant metastasis was found in main portal vein and primary branch, main hepatic vein and branch, main hepatic vein and inferior vena cava by preoperative imaging examination; * planned pregnancy, unplanned pregnancy and pregnancy; * Preoperative child-Pugh grading standard of liver function was Grade C. * Disease researchers that the investigator considers inappropriate to participate in this clinical trial.
Where this trial is running
Guangzhou, Guangdong
- Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Chihua Fang, MD
- Email: fangchihua@smu.edu.cn
- Phone: 13609700805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.