Hepatocellular CarcinomaPhase 1NCT06204835
ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery
A Phase 1 study testing RD-Cy7 fluorophore in people with Hepatocellular Carcinoma, run by Institute of Automation, Chinese Academy of Sciences at 2 sites in China.
Trial summary
In this study, the investigators will detect hepatocellular carcinoma lesions using fluoescence imaging with ITGA6 targeting probes during tumor resection surgery. The aim is to evaluate wether intraoperative fluorescence imaging targeting ITGA6 can help to improve the detction effect of hepatocellular carcinoma, and… 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?
- RD-Cy7 fluorophore
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesChina
- Study dates
- 7 Jan 2024to 31 Dec 2039
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 hepatocellular carcinoma.
- Planned to receive hepatectomy.
- Liver function Child-Pugh A.
- ITGA6 was validated highly expressed preoperatively.
- Aged 18 to 80, and the expected lifetime is longer than 6 months.
- Approved to sign the informed consent.
Who cannot join
- Allergic to Cy7.
- Enrolled in other trials in the past 3 months.
- Another malignant tumor was 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Guangdong
Guangzhou, Guangdong
Xiaojing Shi, Ph.D, 13261798652, shixiaojing2017@ia.ac.cn
- Recruiting
Sichuan
Luzhou, Sichuan
Xiaojing Shi, PhD, 13261798652, shixiaojing2017@ia.ac.cn
About this study
Official title: ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery of HCC Patients
In this study, the investigators will detect hepatocellular carcinoma lesions using fluoescence imaging with ITGA6 targeting probes during tumor resection surgery. The aim is to evaluate wether intraoperative fluorescence imaging targeting ITGA6 can help to improve the detction effect of hepatocellular carcinoma, and finally help the accurate surgical resection.
The main purposes of this study include:
- To raise the detection rate of hepatocellular carcinoma intraoperatively using the novel NIR-II fluorescence molecular imaging and the ITGA6 targeting probe.
- To validate the safety and effectiveness of the proposed ITGA6 targeting probes for clinical application.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- RD-Cy7 fluorophore
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD-Cy7 fluorophoreDrug
Fluorophore targeting ITGA6 that is overexpressed in HCC cells
| Study group | Role | What they receive |
|---|---|---|
| RDCy7 Intraoperative Fluorescence | Experimental | The patients will receive an injection of fluorophore (RDCy7) before the surgery. Then intraoperative fluorescence imaging will be performed to guide lesion resection. Receives: Drug: RD-Cy7 fluorophore |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCC lesions
Numbers of intraoperatively detected hepatocellular carcinoma lesions.
Measured: During hepatocellular resection surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start7 Jan 2024
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2039 (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.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Automation, Chinese Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenhua Hu, Institute of Automation, Chinese Academy of Sciences
- Investigators
- Zhenhua Hu, Ph. D, Principal investigator, Institute of Automation, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204835
- Sponsor's protocol ID
- ITGARD7
- Status last verified
- May 2024
- First submitted
- 3 Jan 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No publications available
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery of HCC Patients
- ClinicalTrials.gov ID
- NCT06204835
- Acronym / sponsor ID
- ITGARD7
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Institute of Automation, Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 7 Jan 2024 (actual)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2039 (estimated)
- First posted
- 12 Jan 2024 (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.
In this study, the investigators will detect hepatocellular carcinoma lesions using fluoescence imaging with ITGA6 targeting probes during tumor resection surgery. The aim is to evaluate wether intraoperative fluorescence imaging targeting ITGA6 can help to improve the detction effect of hepatocellular carcinoma, and finally help the accurate surgical resection.
The main purposes of this study include:
- To raise the detection rate of hepatocellular carcinoma intraoperatively using the novel NIR-II fluorescence molecular imaging and the ITGA6 targeting probe.
- To validate the safety and effectiveness of the proposed ITGA6 targeting probes for clinical application.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RDCy7 Intraoperative Fluorescence | Experimental | Drug: RD-Cy7 fluorophoreThe patients will receive an injection of fluorophore (RDCy7) before the surgery. Then intraoperative fluorescence imaging will be performed to guide lesion resection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who have been diagnosed with hepatocellular carcinoma.
- Planned to receive hepatectomy.
- Liver function Child-Pugh A.
- ITGA6 was validated highly expressed preoperatively.
- Aged 18 to 80, and the expected lifetime is longer than 6 months.
Key exclusion criteria (6 listed)
- Allergic to Cy7.
- Enrolled in other trials in the past 3 months.
- Another malignant tumor was found.
- Undesirable function of heart, lung, kidney, or any other organs.
- Unable to tolerate a hepatectomy.
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 |
|---|---|---|
| RD-Cy7 fluorophoreFluorophore targeting ITGA6 that is overexpressed in HCC cells | Drug | RDCy7 Intraoperative Fluorescence |
Primary outcome
HCC lesions
Time frame: During hepatocellular resection surgery.
Numbers of intraoperatively detected hepatocellular carcinoma lesions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: No. No publications available
Related trials for Hepatocellular Carcinoma
Not yet recruitingPhase 3
Personalized Adaptive Radiotherapy for Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC)
Not yet recruiting
Overcoming Immunotherapy Resistance in Hepatocellular Carcinoma
Hepatocellular Carcinoma Non-Resectable
RecruitingPhase 2
Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma
Hepatocellular Carcinoma, HCC
Active, not recruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
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.
Zhenhua Hu, Ph. D principal investigator
Institute of Automation, Chinese Academy of Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RD-Cy7 fluorophore in people with Hepatocellular Carcinoma, run by Institute of Automation, Chinese Academy of Sciences at 2 sites 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 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: looking for participants now, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaojing Shi, PhD (13261798652, shixiaojing2017@ia.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCC lesions (time frame: During hepatocellular resection surgery.). 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 22 May 2024.