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

Nextbiomedical

Status: Enrolling

Conditions: Liver Cancer (Primary and Metastatic)

Treatments: Device: NexGel

Study type: Interventional

Funder types: Industry

Identifiers

NCT06229080

GuardGel NXG001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Test group

Experimental group

Description:

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

Treatment:

Device: NexGel