Radiofrequency Ablation of Pulmonary Tumors Response Evaluation

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.

Inclusion criteria

• adult (> 18 years) male or female patient
• patient has biopsy-proven NSCLC or lung metastasis
• patient has been rejected for surgery and has been considered unfit for radiation therapy or chemotherapy
• patient has as many as 3 tumors per lung, each 3.5 cm or smaller in greatest diameter, by CT scan
• tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart
• tumors are accessible by percutaneous route
• patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• patient has platelet count > 100 x 109 /L and international normalized ratio ≤ 1.5
• patient has signed written informed consent prior to any study specific procedures.

Exclusion criteria

• patient has undergone previous pneumonectomy
• patient is considered at high-risk for RF ablation due to major co-morbid medical conditions
• patient has more than 3 tumors / lung
• patient has at least one tumor > 3.5 in greatest diameter
• tumor is associated with atelectasis or obstructive pneumonitis
• patient has renal failure requiring hemodialysis or peritoneal dialysis
• patient has active clinically serious infection
• patient has history of organ allograft
• patient has history of substance abuse or any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results
• patient is pregnant or breast-feeding
• patient has ECOG performance status > 2
• patient has platelet count ≤ 100 x 109 /L or international normalized ratio > 1.5.