Impact of Y90 Radiation Segmentectomy on HCC

Mount Sinai Health System

Status

Completed

Conditions

Hepatocellular Carcinoma

Treatments

Radiation: Radiation Segmentectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03248375

GCO 15-0980

Details and patient eligibility

About

The aim of this pilot study is to assess the efficacy of radiation segmentectomy with Theraspheres in patients with unresectable hepatocellular carcinoma that would qualify for thermal ablation as per the BCLC guidelines, but are unable to receive thermal ablation due to unfavorable location of target lesions.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age greater than 18 years, regardless of race or gender
Hepatocellular Carcinoma confirmed by histology for non-cirrhotic patients or non-invasive criteria according to AASLD for cirrhotic patients
Child-Pugh class A or B7 without ascites
Single tumor nodule ≤ 3 cm with a maximum distance of 5 mm from portal vein, hepatic vein, inferior vena cava, diaphragm, heart, stomach, bowel, liver capsule, gallbladder, bile duct
No prior locoregional treatment or external beam therapy of current HCC (recurrent HCC after resection may be included)
No confirmed extrahepatic metastases
No evidence of macrovascular invasion
ECOG 0
Albumin > 3.0 g/dL
PLT ≥ 40 x103/μL
WBC ≥ 1.5 x103/μL
AST/ALT ≤ 5 times the upper limit of normal (U/L)
Creatinine ≤ 2.0 mg /dL
No indication for any possible curative treatment after multidisciplinary assessment (surgery, ablation)
No contraindication to angiography or selective visceral catheterization
No history of severe allergy or intolerance to contrast agents, narcotics, sedatives.
Negative serum pregnancy test
Signed informed consent form