CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
radiofrequency ablationdevice
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Diagnosis of hepatocellular carcinoma (HCC) meeting one of: histologically confirmed, discrete non-biopsied hypervascular tumor >2 cm on 2 imaging studies, or hypervascular tumor >2 cm on 1 imaging study with AFP ≥400 ng/mL, or non-biopsied hypervascular tumors on 2 consecutive imaging studies with documented growth >1 cm
  • ✓Histologically confirmed cirrhosis OR typical imaging findings of cirrhosis (nodular liver, splenomegaly, varices, or ascites) on CT/MRI
  • ✓Single hepatic tumor >3.0 cm but ≤5.0 cm in diameter, OR 3 or fewer hepatic tumors ≤3.0 cm in diameter
  • ✓Tumor(s) ≥1 cm from main, right, and left portal veins and hollow viscera; no hepatic or portal vein tumor invasion
Key exclusion· 10
  • ✕Excessive intrahepatic tumor burden: >3 hepatic tumors, OR single tumor >5 cm, OR >3 vague hypervascular nodules >1 cm
  • ✕Uncorrectable coagulopathy
  • ✕Creatinine >2.0 mg/dL
  • ✕Active symptomatic bacterial or fungal infection that is newly diagnosed and/or requires treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00132041
NCT00132041N/ACompleted
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Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients

American College of Radiology Imaging Network·interventional·Posted Aug 19, 2005·Updated Sep 10, 2020

In Brief

A clinical study evaluating radiofrequency ablation for Liver Cancer. Completed, enrolled 51 participants across 18 sites.

Detailed Summary

RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. CT-, MRI-, or ultrasound-guided radiofrequency ablation may be an effective treatment for liver cancer and cirrhosis. PURPOSE: This phase II trial is studying how well radiofrequency ablation works in treating patients with liver cancer and cirrhosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 19, 2005
Enrollment StartDec 1, 2005
Primary CompletionAug 1, 2009
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 20.9 years ago

Interventions

radiofrequency ablationdevice