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

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.

Study Overview

• Status: Completed
• Conditions: Liver Cancer (Primary and Metastatic)
• Intervention / Treatment: Device: NexGel

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic recanalization of the transiently embolized hepatic arteries	Angiographic recanalization of the transiently embolized hepatic arteries (grade 0, completely occluded; grade 1, antegrade flow visible only near the RGM injection point; grade 2, sluggish antegrade flow visible to the periphery; and grade 3, completely patent)	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)	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	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	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	Objective Tumour Response will be assessed by the investigators on CT/MRI image analysis	6 months after radioembolization
Serious adverse event	Serious adverse event	For 6 months from radioembolization

Collaborators and Investigators

• Sponsor: Next Biomedical Co., Ltd.
• Investigators: Principal Investigator: Jin Woo Choi, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): January 20, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Liver Neoplasms
• Other Study ID Numbers: GuardGel NXG001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No