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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Seattle Children's Hospital
Seattle, Washington, United States
Assess if quality of life was improved by RFA for the benign lesions
Time frame: baseline, 3 months and potentially 6 and 12 months following RFA
Assess the response to RF ablative therapy by pain relief from painful benign or malignant lesions.
Time frame: baseline, 3 months and potentially 6 and 12 months following RFA
Evaluate the rate of short-term ablation of benign lesions produced by RFA
Time frame: baseline, 3 months and potentially 6 and 12 months following RFA
Assess toxicity related to all RFA procedures using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Time frame: within 3 months (potentially 6-12 months) following RFA
Assess the response to RFA by malignant tumor markers (e.g. AFP)
Time frame: 1, 3, 6, and 12 months following RFA
Assess if quality of life was improved by RFA for patients with malignant lesions
Time frame: baseline, 3, 6 and 12 months
Evaluate the proportion of malignant lesions that show short-term ablation produced by RFA.
Time frame: 3 months post Radiofrequency Ablation (RFA), as compared to 1 month post RFA imaging
Determine the rate of durable ablation in malignant lesions that achieve short-term ablation by RFA
Time frame: 12 months post RFA
Assess the time to malignant tumor progression (as defined by RECIST) of lesions treated with RFA
Time frame: 1, 3, 6, and 12 months post RFA
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