Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors

This study has been completed.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00610844
First received: January 28, 2008
Last updated: February 15, 2008
Last verified: November 2007

January 28, 2008
February 15, 2008
April 2004
May 2006   (final data collection date for primary outcome measure)
rate of incomplete treated tumors [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00610844 on ClinicalTrials.gov Archive Site
pathologic tissue changes, rate of major and minor complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors
Evaluation of Effectiveness of Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lung Cancer
  • Lung Metastasis
Procedure: pulmonary radiofrequency ablation
CT-guided pulmonary radiofrequency ablation
Experimental: 1
pulmonary radiofrequency ablation
Intervention: Procedure: pulmonary radiofrequency ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
Not Provided
May 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00610844
LungRFA_V1
Not Provided
Philippe L. Pereira, MD, Department of Diagnostic Radilogy
University Hospital Tuebingen
Not Provided
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
University Hospital Tuebingen
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP