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Completed

NCT Number: NCT06229080

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

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.

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Key information

Conditions

Liver Cancer (Primary and Metastatic) Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Day 1, The day after radioembolization

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

Secondary outcomes

  1. Angiographic recanalization of the transiently embolized hepatic arteries

    Time frame: After Y-90 microsphere infusion, 30 minutes after embolization

    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)

  2. 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)

    Time frame: Day 1, The day after radioembolization

    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)

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

    Time frame: 6 months after radioembolization

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

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

    Time frame: 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

  5. Response to the treatment, as assessed by mRECIST

    Time frame: 6 months after radioembolization

    Objective Tumour Response will be assessed by the investigators on CT/MRI image analysis

  6. Serious adverse event

    Time frame: For 6 months from radioembolization

    Serious adverse event

Sponsors and collaborators

Lead sponsor

Next Biomedical Co., Ltd.

Industry

Registry information

Acronym: SEGWAY

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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