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
  Purpose

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 Intervention Phase
Lung Cancer
Lung Metastasis
Procedure: pulmonary radiofrequency ablation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Effectiveness of Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • rate of incomplete treated tumors [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pathologic tissue changes, rate of major and minor complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: April 2004
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
pulmonary radiofrequency ablation
Procedure: pulmonary radiofrequency ablation
CT-guided pulmonary radiofrequency ablation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610844

Locations
Germany
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
  More Information

No publications provided

Responsible Party: Philippe L. Pereira, MD, Department of Diagnostic Radilogy
ClinicalTrials.gov Identifier: NCT00610844     History of Changes
Other Study ID Numbers: LungRFA_V1
Study First Received: January 28, 2008
Last Updated: February 15, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:
lung cancer
lung metastasis
radiofrequency ablation

Additional relevant MeSH terms:
Neoplasm Metastasis
Lung Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014