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Completed

NCT Number: NCT00610844

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Diagnostic Radiology

Tübingen, Baden-Wurttemberg, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pulmonary radiofrequency ablation

Procedure

CT-guided pulmonary radiofrequency ablation

Primary outcomes

  1. rate of incomplete treated tumors

    Time frame: 3 days

Secondary outcomes

  1. pathologic tissue changes, rate of major and minor complications

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
First posted
Feb 8, 2008
Registry last updated
Feb 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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