Liver CancerICGMFITinPLCNCT05160740
Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer
A study testing Indocyanine green for injection in people with Liver Cancer, run by Zhujiang Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Indocyanine green for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510282
Chihua Fang, M.D, (+86)2062782568, fangch_dr@163.com
Xiaojun Zeng, (+86)2062782568, zengxiaojun95@126.com
About this study
Official title: 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).
Read the 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.
- Conditions
- Liver Cancer
- Being tested
- Indocyanine green for injection
- Keywords
- indocyanine green, local resection
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green for injectionDrug
Also called ICG
ICG will be injected to participants preoperatively for molecular fluorescence image
| Study group | Role | What they receive |
|---|---|---|
| ICG molecular fluorescence imaging guided surgery | Experimental | ICG molecular fluorescence imaging will be used in local hepatectomy of primary liver cancer in this group Receives: 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 Receives: Drug: Indocyanine green for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival rate
No tumor recurrence within 3 years after surgery divided by total number of patients
Measured: 36 months
Secondary outcomes (19)
Positive margin rate
Compare positive margin rate in both groups
Measured: 14 days
Negative margin rate
Compare negative margin rate in both groups
Measured: 14 days
Length of the shortest cutting edge
The shortest distance between tumor and resection margin was compared between the two groups by pathological diagnosis
Measured: 14 days
Operation time
Compare operation time in both groups
Measured: 1 day
Intraoperative blood loss
Compare intraoperative blood loss in both groups
Measured: 1 day
Intraoperative blood transfusion volume
Compare intraoperative blood transfusion volume in both groups
Measured: 1 day
The number of small lesions of HCC
Small lesions detected by ICG fluorescence and confirmed by pathology in the intervention group
Measured: 14 days
Residual tumor at the margin of liver cross-section
The number of residual tumors confirmed by ICG fluorescence detection at the liver margin of the intervention group
Measured: 14 days
Intraoperative biliary fistula detection rate
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.
Measured: 1 day
Extrahepatic metastases of primary hepatocellular carcinoma
The number of extrahepatic metastases of primary liver cancer detected by ICG and confirmed by pathology in the intervention group
Measured: 14 days
Postoperative hospital stay
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.
Measured: 30 days
Postoperative liver function index 1
Compare the levels of Alanine aminotransferase on postoperative days 1, 3, and 5 in both groups
Measured: 5 days
Postoperative liver function index 2
Compare the levels of Aspartate aminotransferase on postoperative days 1, 3, and 5 in both groups
Measured: 5 days
Postoperative liver function index 3
Compare the levels of serum albumin on postoperative days 1, 3, and 5 in both groups
Measured: 5 days
Postoperative liver function index 4
Compare the levels of total bilirubin on postoperative days 1, 3, and 5 in both groups
Measured: 5 days
Postoperative hemoglobin
Compare hemoglobin on postoperative days 1, 3, and 5 in both groups
Measured: 5 days
Postoperative platelets
Compare platelets on postoperative days 1, 3, and 5 in both groups
Measured: 5 days
Prothrombin time
Compare prothrombin time on postoperative days 1, 3, and 5 in both groups
Measured: 5 days
Mortality rates
Perioperative death was defined as death occurring within 90 days after surgery
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start23 Sep 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chihua Fang,MD, Zhujiang Hospital
- Investigators
- Chihua Fang, MD, Study chair, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160740
- Sponsor's protocol ID
- 2021-KY-090-01
- Acronym
- ICGMFITinPLC
- Status last verified
- Jan 2022
- First submitted
- 9 Nov 2021
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Clinical Trial of Indocyanine Green Molecular Fluorescence Imaging in the Diagnosis and Treatment of Primary Liver Cancer
- ClinicalTrials.gov ID
- NCT05160740
- Acronym / sponsor ID
- ICGMFITinPLC / 2021-KY-090-01
- Conditions
- Liver Cancer
- Keywords
- indocyanine green, local resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICG molecular fluorescence imaging guided surgery | Experimental | Drug: Indocyanine green for injectionICG molecular fluorescence imaging will be used in local hepatectomy of primary liver cancer in this group |
| No ICG molecular fluorescence imaging guided surgery | Placebo comparator | Drug: Indocyanine green for injectionICG molecular fluorescence imaging will not be used in local hepatectomy of primary liver cancer in this group |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine green for injectionAlso: ICGICG will be injected to participants preoperatively for molecular fluorescence image | Drug | ICG molecular fluorescence imaging guided surgery, No ICG molecular fluorescence imaging guided surgery |
Primary outcome
3-year disease free survival rate
Time frame: 36 months
No tumor recurrence within 3 years after surgery divided by total number of patients
19 secondary outcomes
Positive margin rate
Time frame: 14 days
Negative margin rate
Time frame: 14 days
Length of the shortest cutting edge
Time frame: 14 days
Operation time
Time frame: 1 day
Intraoperative blood loss
Time frame: 1 day
Intraoperative blood transfusion volume
Time frame: 1 day
The number of small lesions of HCC
Time frame: 14 days
Residual tumor at the margin of liver cross-section
Time frame: 14 days
Intraoperative biliary fistula detection rate
Time frame: 1 day
Extrahepatic metastases of primary hepatocellular carcinoma
Time frame: 14 days
Postoperative hospital stay
Time frame: 30 days
Postoperative liver function index 1
Time frame: 5 days
Postoperative liver function index 2
Time frame: 5 days
Postoperative liver function index 3
Time frame: 5 days
Postoperative liver function index 4
Time frame: 5 days
Postoperative hemoglobin
Time frame: 5 days
Postoperative platelets
Time frame: 5 days
Prothrombin time
Time frame: 5 days
Mortality rates
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chihua Fang, MD study chair
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine green for injection in people with Liver Cancer, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chihua Fang, MD (13609700805, fangchihua@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival rate (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.