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Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors

Primary Purpose

Lung Cancer, Lung Metastasis

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

pulmonary radiofrequency ablation

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring lung cancer, lung metastasis, radiofrequency ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Diagnostic Radiology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

pulmonary radiofrequency ablation

Outcomes

Primary Outcome Measures

rate of incomplete treated tumors

Secondary Outcome Measures

pathologic tissue changes, rate of major and minor complications

Full Information

NCT ID

NCT00610844

First Posted

January 28, 2008

Last Updated

February 15, 2008

Sponsor

University Hospital Tuebingen

1. Study Identification

Unique Protocol Identification Number

NCT00610844

Brief Title

Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

May 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital Tuebingen

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Lung Metastasis

Keywords

lung cancer, lung metastasis, radiofrequency ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

pulmonary radiofrequency ablation

Intervention Type

Procedure

Intervention Name(s)

pulmonary radiofrequency ablation

Intervention Description

CT-guided pulmonary radiofrequency ablation

Primary Outcome Measure Information:

Title

rate of incomplete treated tumors

Time Frame

3 days

Secondary Outcome Measure Information:

Title

pathologic tissue changes, rate of major and minor complications

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe L Pereira, MD

Organizational Affiliation

Department of Diagnostic Radiology, University of Tübingen

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hermann Aebert, MD

Organizational Affiliation

Department of thoracic surgery, University of Tübingen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Diagnostic Radiology

City

Tübingen

State/Province

ZIP/Postal Code

72076

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors

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