Short-term Embolization Using Gelatin Particles for FloW ModulAtion During Y90 Radioembolization
NCT ID: NCT06229080
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-03-15
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Test group
short-acting gelatin sponge particles (NexGel) will be administered to the hepatic arteries toward the non-tumorous liver.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Next Biomedical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jin Woo Choi
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Jin Woo Choi
Role: primary
Other Identifiers
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GuardGel NXG001
Identifier Type: -
Identifier Source: org_study_id