Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 28, 2008 | ||||||||
| Last Updated Date | February 15, 2008 | ||||||||
| Start Date ICMJE | April 2004 | ||||||||
| Primary Completion Date | May 2006 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
rate of incomplete treated tumors [ Time Frame: 3 days ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00610844 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
pathologic tissue changes, rate of major and minor complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors | ||||||||
| Official Title ICMJE | Evaluation of Effectiveness of Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: pulmonary radiofrequency ablation
CT-guided pulmonary radiofrequency ablation |
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| Study Arm (s) | Experimental: 1
pulmonary radiofrequency ablation
Intervention: Procedure: pulmonary radiofrequency ablation |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 9 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | May 2006 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00610844 | ||||||||
| Other Study ID Numbers ICMJE | LungRFA_V1 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Philippe L. Pereira, MD, Department of Diagnostic Radilogy | ||||||||
| Study Sponsor ICMJE | University Hospital Tuebingen | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital Tuebingen | ||||||||
| Verification Date | November 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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