NCT06229080

Short-term Embolization Using Gelatin Particles for FloW ModulAtion During Y90 Radioembolization

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Next Biomedical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The SEGWAY trial is a prospective, single-arm clinical study to evaluate the efficacy and safety of flow diversion to protect non-tumorous liver function using short-acting gelatin sponge particles during Yttrium-90 radioembolization of liver cancer.

Detailed description

Short-acting gelatin sponge particles will be used during radioembolization to protect normal liver tissue in patients with liver cancer whose treatment field encompasses a substantial portion of non-tumorous liver tissue. Recanalization of the embolized hepatic artery will be assessed by angiography within 30 minutes following the procedure. Suppression of Y90 microsphere delivery to the protected, non-tumorous liver tissue will be evaluated using Y90 PET-CT imaging, by comparing the protected regions to non-protected, non-tumorous regions within the perfused area. Enhanced tumor uptake of Y90 microspheres will be quantified using the tumor-to-normal liver ratio (TNR), calculated by comparing pre-procedure SPECT-CT with post-procedure PET-CT data. Finally, preservation of liver function in protected tissue relative to unprotected tissue will be assessed six months post-procedure using signal intensity ratios on hepatobiliary phase images obtained from gadoxetic acid-enhanced MRI.

Conditions

• Liver Cancer (Primary and Metastatic)

Interventions

Type	Name	Description
DEVICE	NexGel	When a planned perfused area includes two or more Couinaud segments and more than 50% of the target area is non-tumorous liver, short-acting gelatin sponge particles (NexGel) will be administered to the hepatic arteries toward the non-tumorous liver. The embolization particles will be prepared by mixing one vial of the particles with 5 mL of iodinated contrast agents and intra-arterially delivered with a microcatheter 2.0-Fr or larger. After confirming the disappearance or substantial reduction of liver parenchymal staining of the embolized area on angiography, radioembolization using Y90 glass or resin microspheres will be conducted. Digital subtraction angiography will be performed 30 minutes after the transient embolization to identify recanalization of the transiently embolized hepatic arteries.

Timeline

• Start date: 2023-03-15
• Primary completion: 2025-01-20
• Completion: 2025-07-30
• First posted: 2024-01-29
• Last updated: 2026-02-12

Locations

1 site across 1 country: South Korea