- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00610844
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
-
-
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
|
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
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
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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