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

NCT06229080 | Completed

• 1 other identifier: GuardGel NXG001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Cancer (Primary and Metastatic)

Outcome Measures

Primary Outcomes (1)

• Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver

  Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver

  Day 1, The day after radioembolization

Secondary Outcomes (6)

• Angiographic recanalization of the transiently embolized hepatic arteries

  After Y-90 microsphere infusion, 30 minutes after embolization

• Tumor-to-normal liver ratio change between the pre-treatment SPECT-CT (99mTc-MAA injection without transient embolization) and post-treatment PET-CT (Y90 injection with transient embolization)

  Day 1, The day after radioembolization

• Ratio of the Relative volumetric changes between the protected perfused liver and unprotected perfused liver

  6 months after radioembolization

• Relative signal intensity ratio between the protected perfused liver and unprotected perfused liver on a 20-minute delayed scan of gadoxetic acid-enhanced MRI

  6 months after radioembolization

• Response to the treatment, as assessed by mRECIST

  6 months after radioembolization

Study Arms (1)

Test group

EXPERIMENTAL

short-acting gelatin sponge particles (NexGel) will be administered to the hepatic arteries toward the non-tumorous liver.

Device: NexGel

Interventions

NexGel DEVICE

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.

Test group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 years or older
• Patients diagnosed with primary or metastatic liver cancer based on histological and/or radiological findings
• Patients determined, following medical, surgical, or multidisciplinary evaluation, to be best treated by radioembolization
• Patients with no history of local treatments (e.g., ablation, chemoembolization) to the same hepatic lobe within the past year
• Child-Pugh class A
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
• Patients whose treatment area, as determined by planning angiography, includes at least two liver segments
• Patients for whom normal liver tissue constitutes 50% or more of the treatment volume

You may not qualify if:

• Liver cancer with vascular invasion
• 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
• Patients who have undergone biliary-enteric anastomosis
• Patients with an estimated lung dose of 30 Gy or higher on pre-procedure 99mTc-MAA imaging
• Patients with a known contraindication to gelatin use

Sponsors & Collaborators

• Next Biomedical Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Liver Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jin Woo Choi

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 29, 2024
• Study Start: March 15, 2023
• Primary Completion: January 20, 2025
• Study Completion: July 30, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

KR (1)