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Radiofrequency Ablation of Tumors

24. april 2017 opdateret af: St. Jude Children's Research Hospital

Radiofrequency Ablation of Tumors (RFA) A Phase I Study

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.

Studieoversigt

Status

Afsluttet

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38105
        • St. Jude Children's Research Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To determine the safety of RFA in patients with childhood acquired tumors
Tidsramme: 5 years
5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Matthew Krasin, MD, St. Jude Children's Research Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2003

Primær færdiggørelse (Faktiske)

1. oktober 2008

Studieafslutning (Faktiske)

1. oktober 2008

Datoer for studieregistrering

Først indsendt

24. juni 2008

Først indsendt, der opfyldte QC-kriterier

25. juni 2008

Først opslået (Skøn)

26. juni 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. april 2017

Sidst verificeret

1. juni 2011

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • RFA

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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