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CompletedNCT00705497Updated Apr 26, 2017

Radiofrequency Ablation of Tumors

A Phase 1 interventional study of Radiofrequency Tumor Ablation in Primary Tumors and Metastatic Tumors, sponsored by St. Jude Children's Research Hospital. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-04-26.

Sponsored by St. Jude Children's Research Hospital · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Tumors
  • Metastatic Tumors

Keywords

  • Radiofrequency tumor ablation
  • RFA
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 31 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

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

  • Intrahepatic metastases not amenable to other therapy
  • Primary hepatic tumor if RF ablation of a portion of the tumor can lead to primary tumor resection rather than hepatic transplantation
  • Single primary or multiple tumors in the liver
  • At least one over 0.5 cm in diameter
  • Edge of lesion not contiguous with main hepatic or common biliary duct.

Musculoskeletal lesions

  • Local or regional recurrence of primary bone or soft tissue tumor not amenable to resection or radiotherapy
  • Osseous, soft tissue or lymph node metastases not amenable to resection or radiotherapy.
  • Head, neck, spine, extremity, chest wall, flank, abdominal wall, or pelvic bone or girdle lesions are treatable under this protocol
  • RFA target \< 50% of axial area in weight bearing bone unless reinforced with internal fixation (bone cement infusion) or in non-ambulatory patient.

Lung lesions

  • No supplemental oxygenation is required.
  • Metastatic solid tumor that has recurred or progressed after primary thoracotomy or thoracoscopic removal that is not amenable to radiotherapy, surgery or chemotherapy
  • In the investigator's opinion, no supplemental oxygen will likely be required at rest for more than 30 days after RF ablation.
  • Tumor burden \< 20% of lung volume
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    1

    Procedure: Radiofrequency Tumor Ablation

Interventions

  • ProcedureRadiofrequency Tumor Ablation

    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.

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What researchers measure

Primary outcomes

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

    Time frame: 5 years

07

Study locations

1 site
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00705497
Lead sponsor
St. Jude Children's Research Hospital
Responsible party
Sponsor
First posted
Jun 26, 2008
Start date
Jan 2003
Primary completion
Oct 2008
Completion
Oct 2008
Last update
Apr 26, 2017

Study contacts

Matthew Krasin, MD
principal investigator · St. Jude Children's Research Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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