Using fluorescence imaging to improve surgery for liver cancer
ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery of HCC Patients
This study is testing a new imaging technique to help surgeons find liver cancer tumors more easily during surgery, aiming to improve the accuracy of tumor removal for patients.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Institute of Automation, Chinese Academy of Sciences Academic / other |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT06204835 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the detection of hepatocellular carcinoma lesions during surgical resection by utilizing NIR-II fluorescence imaging with ITGA6 targeting probes. The investigators will assess whether this innovative imaging technique can increase the intraoperative detection rate of liver tumors, thereby facilitating more accurate surgical removal. The study will also evaluate the safety and effectiveness of the ITGA6 targeting probes for clinical use in patients undergoing hepatectomy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 diagnosed with hepatocellular carcinoma who are scheduled for hepatectomy and have liver function classified as Child-Pugh A.
Not a fit: Patients with other malignant tumors, significant organ dysfunction, or those unable to tolerate surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise surgical interventions for liver cancer, potentially improving patient outcomes.
How similar studies have performed: While the use of fluorescence imaging in surgery is an emerging field, this specific approach targeting ITGA6 is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who have been diagnosed with hepatocellular carcinoma. 2. Planned to receive hepatectomy. 3. Liver function Child-Pugh A. 4. ITGA6 was validated highly expressed preoperatively. 5. Aged 18 to 80, and the expected lifetime is longer than 6 months. 6. Approved to sign the informed consent. Exclusion Criteria: 1. Allergic to Cy7. 2. Enrolled in other trials in the past 3 months. 3. Another malignant tumor was found. 4. Undesirable function of heart, lung, kidney, or any other organs. 5. Unable to tolerate a hepatectomy. 6. The researchers considered inappropriate to be included.
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- Guangdong — Guangzhou, Guangdong, China (Recruiting)
- Sichuan — Luzhou, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: Zhenhua Hu, Ph. D — Institute of Automation, Chinese Academy of Sciences
- Study coordinator: Xiaojing Shi, PhD
- Email: shixiaojing2017@ia.ac.cn
- Phone: 13261798652
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.