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Tracking Information | |||||
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First Received Date † | June 24, 2008 | ||||
Last Updated Date | June 25, 2008 | ||||
Start Date † | January 2003 | ||||
Current Primary Outcome Measures † |
To determine the safety of RFA in patients with childhood acquired tumors [ Time Frame: 5 years ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00705497 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Radiofrequency Ablation of Tumors | ||||
Official Title † | Radiofrequency Ablation of Tumors (RFA) A Phase I Study | ||||
Brief Summary | Background: This prospective study was designed to be the first to evaluate the toxicity of radiofrequency ablation (RFA) in patients with recurrent pediatric solid tumors. Methods: From 2003 through 2006, we conducted a phase I, IRB-approved study of RFA for recurrent solid tumors. A multidisciplinary cancer management team selected appropriate candidates for the study. Imaging-guided RFA was performed percutaneously. Response was assessed at 3 months. Repeat RFA was performed for some incompletely ablated or new lesions. |
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Detailed Description | |||||
Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † |
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Intervention † | Procedure: Radiofrequency Tumor Ablation | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 31 | ||||
Estimated Completion Date | October 2008 | ||||
Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria: General
Hepatic lesions
Musculoskeletal lesions
Lung lesions
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Gender | Both | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00705497 | ||||
Responsible Party | Matthew Krasin MD, St. Jude Children's Research Hospital | ||||
Secondary IDs †† | |||||
Study Sponsor † | St. Jude Children's Research Hospital | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | St. Jude Children's Research Hospital | ||||
Verification Date | June 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |