Using gelatin particles to protect healthy liver tissue during Y90 radioembolization for liver cancer
Short-term Embolization Using Gelatin Particles for FloW ModulAtion During Y90 Radioembolization
This study is testing if using special gelatin particles during a liver cancer treatment can help protect healthy liver tissue while improving the treatment's effectiveness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Next Biomedical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06229080 on ClinicalTrials.gov |
What this trial studies
The SEGWAY trial is a prospective, single-arm clinical study aimed at evaluating the efficacy and safety of using short-acting gelatin sponge particles during Yttrium-90 radioembolization in patients with liver cancer. This approach seeks to protect non-tumorous liver function while enhancing tumor uptake of Y90 microspheres. The study will assess recanalization of the embolized hepatic artery through angiography and evaluate the delivery of Y90 microspheres using PET-CT imaging. Additionally, liver function preservation will be monitored six months post-procedure using MRI.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 years or older with primary or metastatic liver cancer who have a significant portion of non-tumorous liver tissue in the treatment area.
Not a fit: Patients with liver cancer exhibiting vascular invasion or those who have undergone local treatments to the same hepatic lobe within the past year may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve liver function preservation in patients undergoing treatment for liver cancer.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in protecting liver function during radioembolization, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults aged 19 years or older 2. Patients diagnosed with primary or metastatic liver cancer based on histological and/or radiological findings 3. Patients determined, following medical, surgical, or multidisciplinary evaluation, to be best treated by radioembolization 4. Patients with no history of local treatments (e.g., ablation, chemoembolization) to the same hepatic lobe within the past year 5. Child-Pugh class A 6. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower 7. Patients whose treatment area, as determined by planning angiography, includes at least two liver segments 8. Patients for whom normal liver tissue constitutes 50% or more of the treatment volume Exclusion Criteria: 1. Liver cancer with vascular invasion 2. For primary liver cancer, patients who have been diagnosed with a malignancy other than the primary liver cancer within 2 years prior to study enrollment 3. Patients who have undergone biliary-enteric anastomosis 4. Patients with an estimated lung dose of 30 Gy or higher on pre-procedure 99mTc-MAA imaging 5. Patients with a known contraindication to gelatin use
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Jin Woo Choi — Seoul National University Hospital
- Study coordinator: Hansorl Sul
- Email: hssul@nextbiomedical.co.kr
- Phone: +82-32-880-0863
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.