Radiofrequency Ablation of Tumors

NCT00705497 | Completed Phase 1

• 1 other identifier: RFA
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Background: This prospective study was designed to be the first to evaluate the toxicity of radiofrequency ablation (RFA) in patients with recurrent pediatric solid tumors. Methods: From 2003 through 2006, we conducted a phase I, IRB-approved study of RFA for recurrent solid tumors. A multidisciplinary cancer management team selected appropriate candidates for the study. Imaging-guided RFA was performed percutaneously. Response was assessed at 3 months. Repeat RFA was performed for some incompletely ablated or new lesions.

Conditions

Primary Tumors; Metastatic Tumors

Keywords

Radiofrequency tumor ablation; RFA

Outcome Measures

Primary Outcomes (1)

• To determine the safety of RFA in patients with childhood acquired tumors

  5 years

Study Arms (1)

1

EXPERIMENTAL

Procedure: Radiofrequency Tumor Ablation

Interventions

Radiofrequency Tumor Ablation PROCEDURE

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.

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• General
• Any age
• Previously diagnosed malignancy (including aggressive fibromatosis) originally acquired during childhood (\<21 years-of-age)
• Patients who have undergone previous RFA may be enrolled again (different disease site) or receive subsequent ablation (same disease site) as long as the eligibility criteria are met at the time of re-enrollment, or a second ablation on study.
• The subject is medically appropriate for the study as determined by a consensus of professionals at multidisciplinary tumor conference prior to enrollment. This discussion will be documented in the chart of the potential subject to be recruited for this study.
• Histopathological material is available prior to the RF ablation except in patients with obvious tumor recurrence.
• No Pacemakers or Automatic Implantable Cardioverter/Defibrillators (AICDs)
• No tissue burns anticipated from implanted metal
• Normal renal function (Creatinine \< 2mg/dL)
• Absolute neutrophil count (ANC) \> 1000/cu.mm.
• No uncorrectable coagulopathy (INR\>1.5, PTT and PT \> 1.5 x the upper limit of normal)
• No uncorrectable thrombocytopenia (platelet count \< 50,000/mm3)
• Life expectancy over 30 days
• RF ablation targets in the liver, lung or musculoskeletal system that meet the following criteria:
• Hepatic lesions

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Krasin, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 26, 2008
• Study Start: January 1, 2003
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 26, 2017

Record last verified: 2011-06

Locations

US (1)