ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery
ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstitute of Automation, Chinese Academy of Sciences
About this trial
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:
1. To raise the detection rate of hepatocellular carcinoma intraoperatively using the novel NIR-II fluorescence molecular imaging and the ITGA6 targeting probe. 2. To validate the safety and effectiveness of the proposed ITGA6 targeting probes for clinical application.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who have been diagnosed with hepatocellular carcinoma.
Planned to receive hepatectomy.
Liver function Child-Pugh A.
ITGA6 was validated highly expressed preoperatively.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
RD-Cy7 fluorophore
DrugFluorophore targeting ITGA6 that is overexpressed in HCC cells
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: RDCy7 Intraoperative FluorescenceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
HCC lesions
Numbers of intraoperatively detected hepatocellular carcinoma lesions.
Time frame
During hepatocellular resection surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov