SHort-acting Embolization Particles for patients with HEpatocellular carcinoma treated by RaDioembolization (SHEPHERD): a pilot study
- Conditions
- Neoplasms
- Registration Number
- KCT0008148
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
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%
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver
- Secondary Outcome Measures
Name Time Method 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