Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Completed
• CT.gov ID: NCT00610844
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Lung Metastasis	Procedure: pulmonary radiofrequency ablation	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Effectiveness of Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors
• Study Start Date: Apr 1, 2004
• Actual Primary Completion Date: May 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 pulmonary radiofrequency ablation	Procedure: pulmonary radiofrequency ablation; CT-guided pulmonary radiofrequency ablation

Outcome Measures

Primary Outcome Measures

1. rate of incomplete treated tumors [3 days]

Secondary Outcome Measures

1. pathologic tissue changes, rate of major and minor complications [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Diagnostic Radiology	Tübingen	BW	Germany	72076

Sponsors and Collaborators

• University Hospital Tuebingen

Investigators

• Principal Investigator: Philippe L Pereira, MD, Department of Diagnostic Radiology, University of Tübingen
• Principal Investigator: Hermann Aebert, MD, Department of thoracic surgery, University of Tübingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00610844
• Other Study ID Numbers: LungRFA_V1
• First Posted: Feb 8, 2008
• Last Update Posted: Feb 20, 2008
• Last Verified: Nov 1, 2007

• Keywords provided by , ,: lung cancer; lung metastasis; radiofrequency ablation
• Additional relevant MeSH terms: Neoplasm Metastasis

Study Results

No Results Posted as of Feb 20, 2008