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

Not Applicable

Recruiting

• Conditions: Liver Cancer (Primary and Metastatic)
• Interventions: Device: NexGel

• Registration Number: NCT06229080
• Lead Sponsor: Next Biomedical Co., Ltd.

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.

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 Timeline

• Study Start: 2023-03-15
• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver	The day after radioembolization	Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver

Secondary Outcome Measures

Name	Time	Method
Relative signal intensity ratio between the protected perfused liver and unprotected perfused liver on a 20-minute delayed scan of gadoxetic acid-enhanced MRI	Six 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
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)	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)
Angiographic recanalization of the transiently embolized hepatic arteries	30 minutes after embolization	Angiographic recanalization of the transiently embolized hepatic arteries(After 30 minutes of Nexgel embolization, the resumption of the blood vessels is qualitatively evaluated (0 points: not reopened at all \~ 4 points: fully reopened) by an independent radiologist's angiography reading.)
Serious adverse event	For six months from radioembolization	Serious adverse event
Ratio of the Relative volumetric changes between the protected perfused liver and unprotected perfused liver	Six months after radioembolization	Ratio of the Relative volumetric changes between the protected perfused liver and unprotected perfused liver
Response to the treatment, as assessed by mRECIST	Six months after radioembolization	Objective Tumour Response will be assessed by the investigators on CT/MRI image analysis

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of