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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

March 23, 2009
August 28, 2009
June 2007
June 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00868647 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood
Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood: A Phase II Study

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neoplasms, Benign
  • Neoplasms, Malignant
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)
Radiofrequency Ablation
Intervention: Procedure: Radiofrequency ablation (RFA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
60
Not Provided
June 2012   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00868647
RFAII
Yes
Fredric A. Hoffer MD FAAP, FSIR, Seattle Children's Hospital
Seattle Children's Hospital
Not Provided
Principal Investigator: Fredric A Hoffer, MD Seattle Children's Hospital
Seattle Children's Hospital
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP