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

January 21, 2022 updated by: Chihua Fang,MD, Zhujiang Hospital

Multicenter Randomized Controlled Clinical Trial of Indocyanine Green Molecular Fluorescence Imaging in the Diagnosis and Treatment of Primary Liver Cancer

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Indocyanine green molecular imaging technique is often used in the surgical treatment of primary liver cancer. Its application in hepatectomy of primary liver cancer is currently in the stage of case accumulation and clinical research. No prospective study has been conducted to determine the clinical efficacy of indocyanine green molecular imaging for local hepatectomy of primary liver cancer. On the basis of more than 1000 liver resection procedures, the investigators want to apply indocyanine green molecular imaging technology, a cheap, simple and radiation-free method, to guide surgical resection. The purpose is to assist surgical procedures and improve participants' tumor-free survival.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
348

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510282
        • Recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ICG molecular fluorescence imaging guided surgery
ICG molecular fluorescence imaging will be used in local hepatectomy of primary liver cancer in this group
Drug: Indocyanine green for injection
ICG will be injected to participants preoperatively for molecular fluorescence image
Other Names:
  • ICG
Placebo Comparator: No ICG molecular fluorescence imaging guided surgery
ICG molecular fluorescence imaging will not be used in local hepatectomy of primary liver cancer in this group
Drug: Indocyanine green for injection
ICG will be injected to participants preoperatively for molecular fluorescence image
Other Names:
  • ICG

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
3-year disease free survival rate
Time Frame: 36 months
No tumor recurrence within 3 years after surgery divided by total number of patients
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Positive margin rate
Time Frame: 14 days
Compare positive margin rate in both groups
14 days
Negative margin rate
Time Frame: 14 days
Compare negative margin rate in both groups
14 days
Length of the shortest cutting edge
Time Frame: 14 days
The shortest distance between tumor and resection margin was compared between the two groups by pathological diagnosis
14 days
Operation time
Time Frame: 1 day
Compare operation time in both groups
1 day
Intraoperative blood loss
Time Frame: 1 day
Compare intraoperative blood loss in both groups
1 day
Intraoperative blood transfusion volume
Time Frame: 1 day
Compare intraoperative blood transfusion volume in both groups
1 day
The number of small lesions of HCC
Time Frame: 14 days
Small lesions detected by ICG fluorescence and confirmed by pathology in the intervention group
14 days
Residual tumor at the margin of liver cross-section
Time Frame: 14 days
The number of residual tumors confirmed by ICG fluorescence detection at the liver margin of the intervention group
14 days
Intraoperative biliary fistula detection rate
Time Frame: 1 day
The number of cases of successful intraoperative detection of biliary fistula by fluorescence in the intervention group divided by the total number of cases in the intervention group.
1 day
Extrahepatic metastases of primary hepatocellular carcinoma
Time Frame: 14 days
The number of extrahepatic metastases of primary liver cancer detected by ICG and confirmed by pathology in the intervention group
14 days
Postoperative hospital stay
Time Frame: 30 days
Compare Postoperative hospital stay in both groups. Eg: Postoperative hospital stay is the number of days from the day of surgery to the day of discharge.
30 days
Postoperative liver function index 1
Time Frame: 5 days
Compare the levels of Alanine aminotransferase on postoperative days 1, 3, and 5 in both groups
5 days
Postoperative liver function index 2
Time Frame: 5 days
Compare the levels of Aspartate aminotransferase on postoperative days 1, 3, and 5 in both groups
5 days
Postoperative liver function index 3
Time Frame: 5 days
Compare the levels of serum albumin on postoperative days 1, 3, and 5 in both groups
5 days
Postoperative liver function index 4
Time Frame: 5 days
Compare the levels of total bilirubin on postoperative days 1, 3, and 5 in both groups
5 days
Postoperative hemoglobin
Time Frame: 5 days
Compare hemoglobin on postoperative days 1, 3, and 5 in both groups
5 days
Postoperative platelets
Time Frame: 5 days
Compare platelets on postoperative days 1, 3, and 5 in both groups
5 days
Prothrombin time
Time Frame: 5 days
Compare prothrombin time on postoperative days 1, 3, and 5 in both groups
5 days
Mortality rates
Time Frame: 3 months
Perioperative death was defined as death occurring within 90 days after surgery
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhujiang Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Chihua Fang, MD, Zhujiang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-KY-090-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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