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| Sponsor: | Angiodynamics, Inc. |
|---|---|
| Information provided by: | Angiodynamics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00690703 |
Purpose
The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective treatment for malignant lung tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer Pulmonary Metastases |
Device: RF ablation (Rita Medical Systems Model 1500x) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Radiofrequency Ablation of Pulmonary Tumors Response Evaluation: a Prospective, Intention-to-Treat, Multicenter Clinical Trial |
| Enrollment: | 106 |
| Study Start Date: | July 2001 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Treatment
|
Device: RF ablation (Rita Medical Systems Model 1500x)
computed tomography-guided RF ablation with an expandable electrode needle
|
Image-guided RF ablation is accepted as a viable therapeutic choice for patients with early-stage hepatocellular carcinoma or limited hepatic metastatic disease from colorectal cancer, when surgery is precluded (1, 2). Recently, RF ablation has been proposed as a viable option for the treatment of pulmonary malignancies. Experimental studies in animal tumor models have confirmed the effectiveness of RF ablation in the destruction of experimentally-induced pulmonary malignancies (3). Pilot clinical investigations have suggested that the treatment can achieve high proportions of tumor response (4, 5). We designed a prospective, intention-to-treat, multicenter clinical trial aimed at assessing feasibility, safety and effectiveness of RF ablation in the treatment of lung malignancies.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| UCLA Medical Center | |
| Los Angeles, California, United States, 90095 | |
| Australia | |
| University of New South Wales | |
| Sydney, Australia, NSW 2052 | |
| Germany | |
| Ludwig-Maximilians University | |
| Muenchen, Germany, 82152 | |
| University Hospital Essen | |
| Essen, Germany, 45122 | |
| Italy | |
| University of Pisa | |
| Pisa, Italy, 56100 | |
| Institute for Cancer Research and Treatment | |
| Candiolo, Italy, 10060 | |
| United Kingdom | |
| University College Hospital | |
| London, United Kingdom, NW1 2BU | |
| Principal Investigator: | Riccardo Lencioni, MD | University of Pisa, Pisa, Italy |
More Information
| Responsible Party: | University of Pisa, Pisa, Italy ( Riccardo Lencioni ) |
| Study ID Numbers: | 102-00 |
| Study First Received: | June 3, 2008 |
| Last Updated: | June 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00690703 History of Changes |
| Health Authority: | Italy: Ethics Committee; Australia: Human Research Ethics Committee; Germany: Ethics Commission; United Kingdom: Research Ethics Committee; United States: Institutional Review Board |
|
non small cell lung cancer pulmonary metastases radiofrequency ablation |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Carcinoma Neoplasms Neoplastic Processes Pathologic Processes |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasm Metastasis Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |