Hepatocellular CarcinomaPhase 1NCT03793322
The Application of Indocyanine-Green(ICG) Fluorescence Imaging in Hepatocellular Carcinoma
A Phase 1 study testing Indocyanine-Green(ICG) in people with Hepatocellular Carcinoma, run by Zhujiang Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Indocyanine-Green(ICG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2020
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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, MD, (+86)2062782568, s_mountain@126.com
Qingshan Chen, MM, (+86)2062782568, s_mountain@126.com
About this study
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Indocyanine-Green(ICG)
- Keywords
- Hepatocellular Carcinoma, Indocyanine-Green(ICG)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine-Green(ICG)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Indocyanine-Green(ICG) injection group | Experimental | Not described Receives: Drug: Indocyanine-Green(ICG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of detecting small liver tumor by ICG fluorescence.
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.
Measured: 3 Days
The accuracy of positive margins of resection detected by ICG fluorescence.
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.
Measured: 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start1 Jan 2017
- Primary completion1 Jan 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chihua Fang, Principal investigator, China, Guangdong Zhujiang Hospital of The Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793322
- Sponsor's protocol ID
- 201803
- Status last verified
- Jan 2017
- First submitted
- 2 Jan 2019
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Indocyanine-Green(ICG) Fluorescence Imaging in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03793322
- Acronym / sponsor ID
- 201803
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Indocyanine-Green(ICG)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 4 Jan 2019 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indocyanine-Green(ICG) injection group | Experimental | Drug: Indocyanine-Green(ICG) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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(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. | Drug | Indocyanine-Green(ICG) injection group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
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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 principal investigator
China, Guangdong Zhujiang Hospital of The Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Indocyanine-Green(ICG) in people with Hepatocellular Carcinoma, 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 5 inclusion and 6 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 Jan 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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; PHD (+8613609700805, fangch_dr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of detecting small liver tumor by ICG fluorescence. (time frame: 3 Days). The study lists 2 primary outcomes in all. 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 Jan 2019.