Clinical trial NCT06229080: Short-term Embolization Using Gelatin Particles for FloW ModulAtion During Y90 Radioembolization
Official title: Short-term Embolization Using Gelatin Particles for FloW ModulAtion During Y90 Radioembolization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Cancer (Primary and Metastatic)
Lead sponsor: Next Biomedical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver
timeFrame: The day after radioembolization
Secondary outcomes:
measure: Angiographic recanalization of the transiently embolized hepatic arteries
timeFrame: 30 minutes after embolization
measure: 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)
timeFrame: The day after radioembolization
measure: Ratio of the Relative volumetric changes between the protected perfused liver and unprotected perfused liver
timeFrame: Six months after radioembolization
measure: Relative signal intensity ratio between the protected perfused liver and unprotected perfused liver on a 20-minute delayed scan of gadoxetic acid-enhanced MRI
timeFrame: Six months after radioembolization
measure: Response to the treatment, as assessed by mRECIST
timeFrame: Six months after radioembolization
measure: Serious adverse event
timeFrame: For six months from radioembolization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin Woo Choi
role: PRINCIPAL_INVESTIGATOR
References: