NCT00690703

Radiofrequency Ablation of Pulmonary Tumors Response Evaluation

Radiofrequency Ablation of Pulmonary Tumors Response Evaluation: a Prospective, Intention-to-Treat, Multicenter Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Angiodynamics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective treatment for malignant lung tumors.

Detailed description

Image-guided RF ablation is accepted as a viable therapeutic choice for patients with early-stage hepatocellular carcinoma or limited hepatic metastatic disease from colorectal cancer, when surgery is precluded (1, 2). Recently, RF ablation has been proposed as a viable option for the treatment of pulmonary malignancies. Experimental studies in animal tumor models have confirmed the effectiveness of RF ablation in the destruction of experimentally-induced pulmonary malignancies (3). Pilot clinical investigations have suggested that the treatment can achieve high proportions of tumor response (4, 5). We designed a prospective, intention-to-treat, multicenter clinical trial aimed at assessing feasibility, safety and effectiveness of RF ablation in the treatment of lung malignancies.

Conditions

• Non Small Cell Lung Cancer
• Pulmonary Metastases

Interventions

Type	Name	Description
DEVICE	RF ablation (Rita Medical Systems Model 1500x)	computed tomography-guided RF ablation with an expandable electrode needle

Timeline

• Start date: 2001-07-01
• Primary completion: 2006-12-01
• Completion: 2007-12-01
• First posted: 2008-06-05
• Last updated: 2008-06-05

Locations

7 sites across 5 countries: United States, Australia, Germany, Italy, United Kingdom