Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors

February 15, 2008 updated by: University Hospital Tuebingen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Tübingen, BW, Germany, 72076
        • Department of Diagnostic Radiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
pulmonary radiofrequency ablation
Procedure: pulmonary radiofrequency ablation
CT-guided pulmonary radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of incomplete treated tumors
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
pathologic tissue changes, rate of major and minor complications
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (ACTUAL)

May 1, 2006

Study Registration Dates

First Submitted

January 28, 2008

First Submitted That Met QC Criteria

January 28, 2008

First Posted (ESTIMATE)

February 8, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 20, 2008

Last Update Submitted That Met QC Criteria

February 15, 2008

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LungRFA_V1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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