SHort-acting Embolization Particles for patients with HEpatocellular carcinoma treated by RaDioembolization (SHEPHERD): a pilot study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0008148

Enrollment

Registered

2023-02-02

Start date

2023-03-15

Completion date

Unknown

Last updated

2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : When a planned perfused area includes three or more Couinaud segments and more than 50% of the target area is non-tumorous liver, short-acting gelatin sponge particles (NexGel

Nextbiomedical, Incheon, Republic of Korea) 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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a. Age > 18-year-old b. Histologically or radiologically (LI-RADS 4 or 5) diagnosed as hepatocellular carcinoma c. Patients for whom radioembolization was determined as the optimal treatment after hepatologists', hepatic surgeons' or multidisciplinary clinics. d. Treatment-naive patients e. Child-Pugh class A f. Eastern Cooperative Oncology Group performance status 0-2 g. Planned perfused area including three or more Couinaud segments based on angiography h. Non-tumorous liver volume / total perfused area > 50%

Exclusion criteria

Exclusion criteria: a. Hepatocellular carcinoma with vascular invasion on diagnostic imaging b. Hepatocellular carcinoma with extrahepatic spread on diagnostic imaging c. History of active cancer other than hepatocellular carcinoma within recent two years d. Surgical anastomosis of the bile duct and bowel e. Lung shunt fraction = 15% on 99mTc- macroaggregated albumin lung scan f. Patients contraindicated to gelatin

Design outcomes

Primary

Measure	Time frame
Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver	—

Secondary

Measure	Time frame
Angiographic recanalization of the transiently embolized hepatic arteries;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);Relative volumetric changes between the protected perfused liver and unprotected perfused liver;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 response (mRECIST);Serious adverse event	—

Measure

Time frame

Angiographic recanalization of the transiently embolized hepatic arteries;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);Relative volumetric changes between the protected perfused liver and unprotected perfused liver;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 response (mRECIST);Serious adverse event

—

Countries

Korea, Republic of

Contacts

Public ContactHyunJin Kim

Seoul National University Hospital

ronan13@snu.ac.kr+82-2-2072-4177

Outcome results