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Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood: A Phase II Study

Phase 2
Not Enrolling
Neoplasms, Benign, Neoplasms, Malignant

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Trial Information

Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood: A Phase II Study

Inclusion Criteria:

- 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 Criteria:

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess if quality of life was improved by RFA for the benign lesions

Outcome Time Frame:

baseline, 3 months and potentially 6 and 12 months following RFA

Safety Issue:


Principal Investigator

Fredric A Hoffer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seattle Children's Hospital


United States: Institutional Review Board

Study ID:




Start Date:

June 2007

Completion Date:

Related Keywords:

  • Neoplasms, Benign
  • Neoplasms, Malignant
  • Neoplasms



Seattle Children's Hospital Seattle, Washington  98105