Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors

Lung Cancer Clinical Trial

Official title:

Evaluation of Effectiveness of Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610844
• Other study ID #: LungRFA_V1
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2008
• Last updated: February 15, 2008
• Start date: April 2004

Study information

• Verified date: November 2007
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Metastasis

Intervention

Procedure:
• pulmonary radiofrequency ablation
CT-guided pulmonary radiofrequency ablation

Locations

Country	Name	City	State
Germany	Department of Diagnostic Radiology	Tübingen	BW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of incomplete treated tumors		3 days	No
Secondary	pathologic tissue changes, rate of major and minor complications		6 months	Yes