Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT00868647
First received: March 23, 2009
Last updated: August 28, 2009
Last verified: August 2009
  Purpose

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
Neoplasms, Benign
Neoplasms, Malignant
Procedure: Radiofrequency ablation (RFA)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood: A Phase II Study

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Assess the response to RFA by malignant tumor markers (e.g. AFP) [ Time Frame: 1, 3, 6, and 12 months following RFA ] [ Designated as safety issue: No ]
  • Assess if quality of life was improved by RFA for patients with malignant lesions [ Time Frame: baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Determine the rate of durable ablation in malignant lesions that achieve short-term ablation by RFA [ Time Frame: 12 months post RFA ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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
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.
Other Name: Radiofrequency ablation (RFA)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868647

Locations
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Fredric A Hoffer, MD Seattle Children's Hospital
  More Information

No publications provided

Responsible Party: Fredric A. Hoffer MD FAAP, FSIR, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT00868647     History of Changes
Other Study ID Numbers: RFAII
Study First Received: March 23, 2009
Last Updated: August 28, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014