Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors

Phase 2

Completed

• Conditions: Lung Cancer; Lung Metastasis

• Registration Number: NCT00610844
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors.

Detailed Description

Thermal ablation therapy is an increasingly performed technique in the local tumor treatment. Among these techniques, image-guided radiofrequency (RF) ablation attained widespread consideration in the therapy of liver tumors and osteoid osteoma. Promising results of hepatic RF ablation raised expectations to utilize the advantages of image-guided ablation therapy for the treatment of pulmonary malignancies. The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors. Computed tomography-guided RF ablation is performed in local or general anesthesia, followed by surgical resection three days later. An analysis of complete RF ablation and a characterization of tissue response is performed by hematoxylin and eosin staining, immunostaining, and electron microscopy. Adverse effects and complications are recorded.

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2006-05
• Status Verified: 2007-11
• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-01-28
• Study First Posted: 2008-02-08
• Last Update Submitted: 2008-02-15
• Last Update Posted: 2008-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Signed informed consent for radiofrequency ablation and surgery
• Maximum of 3 lung tumors
• Maximum tumor size 5 cm
• Must be able to receive standard surgery

Exclusion Criteria

• Pathological coagulation tests
• Pregnant or breast feeding
• Maximum tumor size more than 5 cm
• Bilateral secondary lung cancer with more than 3 tumors
• Inoperable patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
rate of incomplete treated tumors	3 days

Secondary Outcome Measures

Name	Time	Method
pathologic tissue changes, rate of major and minor complications	6 months

Trial Locations

Locations (1)

Department of Diagnostic Radiology; 🇩🇪 Tübingen, BW, Germany