Status:
COMPLETED
Impact of Y90 Radiation Segmentectomy on HCC
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Not meeting the inclusion criteria
Key Trial Info
Start Date :
August 3 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03248375
Start Date
August 3 2016
End Date
March 31 2021
Last Update
February 13 2023
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029