Liver CancerNCT05394246
Fluorescent-labeled IgG for Liver Tumor Detection
A study testing FluoAB in people with Liver Cancer, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
This study is to evaluate whether intraoperative fluorescence imaging using fluorescent-labeled IgG probe (FluoAB) can help distinguish the tumor and the liver cirrhosis (or the liver parenchyma). The main purposes of this study include: To validate the safety and effectiveness of using FluoAB in hepatic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- FluoAB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2022to 30 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been diagnosed with liver tumor.
- Planned to receive hepatectomy.
- Liver function Child-Pugh A/B.
- The expected lifetime is longer than 6 months.
- Approved to sign the informed consent.
Who cannot join
- Enrolled in other trials in the past 3 months.
- Metastatic lesions were found.
- Undesirable function of heart, lung, kidney, or any other organs.
- Unable to tolerate a hepatectomy.
- The researchers considered inappropriate to be included.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan
Cheng Fang, M.D., 86-13808288878
About this study
Official title: Intraoperative Liver Tumor Imaging Using Fluorescent-labeled Human IgG
This study is to evaluate whether intraoperative fluorescence imaging using fluorescent-labeled IgG probe (FluoAB) can help distinguish the tumor and the liver cirrhosis (or the liver parenchyma).
The main purposes of this study include:
- To validate the safety and effectiveness of using FluoAB in hepatic surgery.
- To raise the surgical precision with guidance by FluoAB fluorescence imaging.
- Conditions
- Liver Cancer
- Being tested
- FluoAB
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoABDrug
Drug Injection: FluoAB (fluorescent-labeled IgG)
| Study group | Role | What they receive |
|---|---|---|
| FluoAB intraoperative fluorescence imaging | Experimental | The patients will receive an injection of FluoAB. Surgery will be performed with guidance by FluoAB fluorescence imaging. Receives: Drug: FluoAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor imaging precision
Sensitivity and specificity of hepatic malignancy detection by fluoAB intraoperative imaging.
Measured: Update with an average of 2 weeks.
Tumor lesions
Numbers of intraoperatively detected tumor lesions.
Measured: Immediately after the hepatic surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start20 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 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.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeyu Zhang, PHD, Chinese Academy of Sciences
- Investigators
- Bo Li, MD., Principal investigator, The Affiliated Hospital Of Southwest Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394246
- Sponsor's protocol ID
- FluoAB-Liver
- Status last verified
- Aug 2023
- First submitted
- 19 May 2022
- Last updated
- 30 Aug 2023
- 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 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Liver Tumor Imaging Using Fluorescent-labeled Human IgG
- ClinicalTrials.gov ID
- NCT05394246
- Acronym / sponsor ID
- FluoAB-Liver
- Conditions
- Liver Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Study start
- 20 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 27 May 2022 (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 is to evaluate whether intraoperative fluorescence imaging using fluorescent-labeled IgG probe (FluoAB) can help distinguish the tumor and the liver cirrhosis (or the liver parenchyma).
The main purposes of this study include:
- To validate the safety and effectiveness of using FluoAB in hepatic surgery.
- To raise the surgical precision with guidance by FluoAB fluorescence imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FluoAB intraoperative fluorescence imaging | Experimental | Drug: FluoABThe patients will receive an injection of FluoAB. Surgery will be performed with guidance by FluoAB fluorescence imaging. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have been diagnosed with liver tumor.
- Planned to receive hepatectomy.
- Liver function Child-Pugh A/B.
- The expected lifetime is longer than 6 months.
- Approved to sign the informed consent.
Key exclusion criteria (5 listed)
- Enrolled in other trials in the past 3 months.
- Metastatic lesions were found.
- Undesirable function of heart, lung, kidney, or any other organs.
- Unable to tolerate a hepatectomy.
- The researchers considered inappropriate to be included.
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 |
|---|---|---|
| FluoABDrug Injection: FluoAB (fluorescent-labeled IgG) | Drug | FluoAB intraoperative fluorescence imaging |
Primary outcome
Tumor imaging precision
Time frame: Update with an average of 2 weeks.
Sensitivity and specificity of hepatic malignancy detection by fluoAB intraoperative imaging.
Tumor lesions
Time frame: Immediately after the hepatic surgery.
Numbers of intraoperatively detected tumor lesions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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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.
Bo Li, MD. principal investigator
The Affiliated Hospital Of Southwest Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FluoAB in people with Liver Cancer, run by Chinese Academy of Sciences 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 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 30 Aug 2023. 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.
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 Zeyu Zhang, Ph.D. (86-18201082715, zhangzeyu@fingerpass.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor imaging precision (time frame: Update with an average of 2 weeks.). 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 30 Aug 2023.