Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors

NCT ID: NCT00610844

Last Updated: 2008-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30

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.

Conditions

Lung Cancer; Lung Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

pulmonary radiofrequency ablation

Group Type: EXPERIMENTAL

pulmonary radiofrequency ablation

Intervention Type: PROCEDURE

CT-guided pulmonary radiofrequency ablation

Interventions

pulmonary radiofrequency ablation

CT-guided pulmonary radiofrequency ablation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Department of Diagnostic Radilogy

Principal Investigators

Philippe L Pereira, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Diagnostic Radiology, University of Tübingen

Hermann Aebert, MD

Role: PRINCIPAL_INVESTIGATOR

Department of thoracic surgery, University of Tübingen

Locations

Department of Diagnostic Radiology

Tübingen, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

LungRFA_V1

Identifier Type: -

Identifier Source: org_study_id