Status:
SUSPENDED
Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood
Lead Sponsor:
Seattle Children's Hospital
Conditions:
Neoplasms, Benign
Neoplasms, Malignant
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Lesion acquired in childhood (at \<21 years of age)
- Any lesion location except CNS
- Any malignant tumor or metastasis
- Any benign lesion (e.g. desmoids, venous or lymphatic vascular anomalies, aneurysmal bone cysts, osteoid osteoma, tongue hypertrophy, or painful neuropathy)
- Patients with malignant disease have had histologic confirmation of disease at initial diagnosis.
- ≥ 90 day life expectancy
- Potential benefit of RFA outweighs risk as determined by PI
- Other local tumor control measures are not recommended for malignant lesion based on review in multidisciplinary team conference or the patient refuses recommended local tumor control measures
- The patient is not expected to become short of breath at rest after RFA (forced vital capacity ≥33% of normal by pulmonary function tests) if pulmonary RFA is considered
Exclusion
- Patients with uncontrolled infection.
- Patients with co-morbidities affecting inclusion criteria above.
- Patients who are pregnant and/or breastfeeding.
- Patients who had a change in chemotherapy within one month before RFA
- Patients who have planned change in chemotherapy and/or radiation therapy (to same site as RFA) interventions within the first three months following RFA.
- Patients should not be considered for pulmonary RFA if they have poorly compliant lungs (recently required mechanical ventilation) or require supplemental oxygen.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00868647
Start Date
June 1 2007
Last Update
September 1 2009
Active Locations (1)
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1
Seattle Children's Hospital
Seattle, Washington, United States, 98105