Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer

NCT05160740 | Unknown

• 1 other identifier: 2021-KY-090-01
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief Summary

The of this study is to explore the clinical outcomes of indocyanine green molecular fluorescence imaging in local resection of primary hepatocellular carcinoma (CNLC Ⅰa stage).

Conditions

Liver Cancer

Keywords

indocyanine green; local resection

Outcome Measures

Primary Outcomes (1)

• 3-year disease free survival rate

  No tumor recurrence within 3 years after surgery divided by total number of patients

  36 months

Secondary Outcomes (19)

• Positive margin rate

  14 days

• Negative margin rate

  14 days

• Length of the shortest cutting edge

  14 days

• Operation time

  1 day

• Intraoperative blood loss

  1 day

Study Arms (2)

ICG molecular fluorescence imaging guided surgery

EXPERIMENTAL

ICG molecular fluorescence imaging will be used in local hepatectomy of primary liver cancer in this group

Drug: Indocyanine green for injection

No ICG molecular fluorescence imaging guided surgery

PLACEBO COMPARATOR

ICG molecular fluorescence imaging will not be used in local hepatectomy of primary liver cancer in this group

Drug: Indocyanine green for injection

Interventions

Indocyanine green for injection DRUG

ICG will be injected to participants preoperatively for molecular fluorescence image

Also known as: ICG

ICG molecular fluorescence imaging guided surgery; No ICG molecular fluorescence imaging guided surgery

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• years old;
• Complete clinical case data;
• limited surgical methods (local resection);
• Voluntarily participate in the study and sign the informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Indocyanine Green; Injections

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Chihua Fang, MD

  Zhujiang Hospital

  STUDY CHAIR

Central Study Contacts

Chihua Fang, MD

CONTACT

13609700805; fangchihua@smu.edu.cn

Xiaojun Zeng

CONTACT

15626104890; zengxiaojun95@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 16, 2021
• Study Start: September 23, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)