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Sponsored by: |
Seattle Children's Hospital |
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Information provided by: | Seattle Children's Hospital |
ClinicalTrials.gov Identifier: | NCT00868647 |
This is a single-center, Phase II study including only patients on whom a decision to conduct radiofrequency ablation (RFA) has already been made. The primary objective of this study assess if quality of life was improved by RFA as assessed at baseline, 3 and potentially 6 and 12 months following RFA for the benign lesions.
RFA is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by heating the probe (using an electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.
RF ablation is an alternative for local tumor control when other treatments (surgery, radiotherapy or chemotherapy) are not feasible (less effective or at higher risk). Thermal ablation at times is the only remaining alternative for patient cure, prolonged survival or palliation. Cryotherapy, and microwave, laser and focused ultrasound are alternative thermal ablation techniques used in adults but there has been no experience in children with these alternative methods.
To be eligible for this study, patients must have acquired lesions at < 21 years of age (central nervous system lesions are excluded from this study). Study participants will have the RFA procedure performed at Seattle Children's and will have follow-up evaluations at various time points post-RFA.
Condition | Intervention | Phase |
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Neoplasms, Benign Neoplasms, Malignant |
Procedure: Radiofrequency ablation (RFA) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood: A Phase II Study |
Estimated Enrollment: | 60 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Radiofrequency Ablation |
Procedure: Radiofrequency ablation (RFA)
Radiofrequency tumor ablation (RFA) is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by heating the probe (using electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Fredric A Hoffer, MD | 206-987-2134 | fred.hoffer@seattlechildrens.org |
Contact: Janna K Stults, BA | 206-987-3691 | janna.stults@seattlechildrens.org |
United States, Washington | |
Seattle Children's Hospital | Recruiting |
Seattle, Washington, United States, 98105 | |
Contact: Fredric A Hoffer, MD 206-987-2134 | |
Contact: Janna K Stults, BA 206-987-3691 |
Principal Investigator: | Fredric A Hoffer, MD | Seattle Children's Hospital |
Responsible Party: | Seattle Children's Hospital ( Fredric A. Hoffer MD FAAP, FSIR ) |
Study ID Numbers: | RFAII |
Study First Received: | March 23, 2009 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00868647 History of Changes |
Health Authority: | United States: Institutional Review Board |
Neoplasms |