David Arthur Woodrum MD, PhD, Presenter: Nothing to Disclose

Thierry Debaere, Abstract Co-Author: Nothing to Disclose

Fereidoun G. Abtin MD, Abstract Co-Author: Nothing to Disclose

Peter John Littrup MD, Abstract Co-Author: Founder, CryoMedix, LLC Research Grant, Galil Medical Ltd Research Grant, Endo Health Solutions Inc Officer, Delphinus Medical Technologies, Inc

Frederic Deschamps, Abstract Co-Author: Nothing to Disclose

Robert D. Suh MD, Abstract Co-Author: Nothing to Disclose

Hussein D. Aoun MD, Abstract Co-Author: Nothing to Disclose

Matthew Raymond Callstrom MD, PhD, Abstract Co-Author: Research Grant, Endocare, Inc Research Grant, Siemens AG

To evaluate safety and preliminary efficacy of CT guided lung cryoablation for lung metastases ≤3.5cm in patients with pulmonary metastatic disease.

Forty patients (24 males,16 females; mean age 63 years) were enrolled in a prospective single arm study to evaluate CT guided lung cryoablation(Galil Medical,Arden Hills, MN) for patients with lung metastases. Inclusion criteria were up to 3 unilaterally or a maximum of 5 metastases bilaterally. Patients were followed with serial CT imaging at 1 week, 3, 6, and 12 months. The primary endpoint for the study is local tumor control assessed by a modified RECIST. Complications were assessed using the CTCAE 4.0

A total of 62 tumors (40 patients) underwent 48 cryoablation procedures. The mean tumor size was 1.4 cm (range 0.3 to 3.2 cm), and 80% (n=32) of patients had unilateral disease. Sedation was general (67%;n=32), conscious/sedation in 31%(n=15), and 2% regional sedation(n=1). Treatment time ranged from 32-272 minutes (mean=101). Nine chest tubes (18%) were placed for pneumothorax but removed in 1 day or less. With the exception of three grade 3 events (non-cardiac chest pain, pneumothorax requiring VATS, and dialysis fistula thrombosis), all other reported adverse events (95.2%) were classified as CTCAE grade 1 or 2. The most common events (48 procedures) occurring within 30 days of the procedure were pneumothorax 50% (n=24), hemorrhage 8% (n=4). All resolved with minimal to no intervention. We did not encountered major hemorrhage to the lung or the pleura. At 3 months, 28 patients (75%) followed up with 100% response rate defined as either stable disease, partial response, or complete response. At 6 months, 15 patients (38%) followed up with a 95% response rate due to one patient having a local failure.

Cryoablation of metastatic lung tumors ≤3.5 cm appears to be a safe. Our preliminary results demonstrate promising local tumor control within the lung.

CT guided lung cryoablation demonstrates safety and preliminary efficacy in treating metastatic lung disease.

Woodrum, D, Debaere, T, Abtin, F, Littrup, P, Deschamps, F, Suh, R, Aoun, H, Callstrom, M, Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients – Safety and Efficacy (ECLIPSE).  Radiological Society of North America 2013 Scientific Assembly and Annual Meeting, December 1 - December 6, 2013 ,Chicago IL. http://archive.rsna.org/2013/13024352.html