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Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases

11. januar 2017 oppdatert av: Mayo Clinic

Percutaneous US and CT-guided Cryoablation of Painful Metastases Involving Bone: A Feasibility Study

RATIONALE: Percutaneous cryoablation may help relieve pain caused by bone metastases.

PURPOSE: This clinical trial is studying the side effects and how well percutaneous cryoablation works in treating patients with painful bone metastases.

Studieoversikt

Detaljert beskrivelse

OBJECTIVES:

  • To confirm the safety of percutaneous cryoablation in the palliative treatment of patients with painful bone metastases.
  • To determine the benefits of cryoablation of painful bone metastases by assessing pain intensity using a standardized Cleeland Brief Pain Inventory (BPI) and quality of life using a standardized SF-8 both before and after treatment.
  • To determine the secondary benefits of cryoablation of painful bone metastases by assessing change in analgesic use following therapy.
  • To determine the level of anesthesia required for cryoablation with a baseline level of conscious sedation planned for each treatment.

OUTLINE: This is a multicenter study.

Patients undergo percutaneous cryoablation to one or two sites of metastatic disease using the Endocare Cryocare system. Patients with a good initial response to treatment (≥ 2 decrease in pain intensity rating on the Brief Pain Inventory) who develop recurrent pain at the same site or a new painful site ≥ 1 month after initial treatment may undergo one additional cryoablation treatment.

Patients complete pain and quality of life questionnaires periodically.

After completion of study treatment, patients are followed periodically for 2 years.

Studietype

Intervensjonell

Registrering (Forventet)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Florida
      • Jacksonville, Florida, Forente stater, 32224
        • Mayo Clinic - Jacksonville
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109-0942
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, Forente stater, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic Cancer Center
    • New York
      • New York, New York, Forente stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Forente stater, 10016
        • NYU Cancer Institute at New York University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02912
        • Brown University School of Medicine
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
      • Milwaukee, Wisconsin, Forente stater, 53215
        • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 120 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed metastatic solid tumor involving or abutting bone (index lesion)

    • If the nature of the metastatic disease has been previously documented, index lesion to be treated does not require further documentation (i.e., biopsy)
  • Pain either refractory to standard care (chemotherapy, radiotherapy, surgery, or analgesics) or patient is considered a poor candidate for conventional therapies

    • Radiation oncology consult is required if the patient is considered clinically to be a candidate for conventional palliative radiotherapy
    • Surgical oncology consult is required if the patient is considered clinically to be a candidate for conventional surgical treatment or is considered at risk for complications resulting from potential fracture
  • Initial pain score ≥ 4 on a scale of 0-10 for the question "Please rate your pain by circling the one number that best describes your pain at its worst in the past 24 hours" on the Cleeland Brief Pain Inventory

    • Pain from ≤ 2 sites of metastatic disease
  • No lesions with evidence for impending fracture involving a weight-bearing bone (> 50% loss of cortical bone at the site)

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 2 months
  • Platelet count ≥ 75,000/mm³
  • ANC > 1,500/mm³ (for patients who have recently been treated with chemotherapy)
  • INR ≤ 1.2
  • Not pregnant or nursing
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

  • More than 3 weeks since prior radiotherapy
  • More than 3 weeks since initiation of a new chemotherapy regimen, including bisphosphonates
  • More than 7 days since prior antiplatelet medications or clopidogrel
  • More than 3 days since prior acetylsalicylic acid (aspirin), ibuprofen, or other NSAIDs
  • No prior treatment of the portion of a lesion within 0.5 cm of the spinal cord or brain, within 0.5 cm of a large abdominal vessel such as the aorta or inferior vena cava, or within 1 cm of bowel or bladder
  • No prior radiofrequency ablation for pain palliation of the same lesion
  • No concurrent regular or low molecular weight heparin or other anticoagulants

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8

Sekundære resultatmål

Resultatmål
Average difference in pre- and post-treatment worst pain score in a 24-hour period, average pain score, and pain relief score at 6, 12, and 24 months
Average amount of pain per patient over the observation period as represented by the area under the curve (AUC) constructed from weekly pain scores on a visual-analogue scale using a score of 0-10
Percentage of patients who are able to reduce analgesic medications

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Samarbeidspartnere

Etterforskere

  • Studiestol: Matthew R. Callstrom, MD, PhD, Mayo Clinic

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2003

Primær fullføring (Faktiske)

1. februar 2013

Studiet fullført (Faktiske)

1. februar 2013

Datoer for studieregistrering

Først innsendt

1. februar 2008

Først innsendt som oppfylte QC-kriteriene

1. februar 2008

Først lagt ut (Anslag)

6. februar 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

12. januar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. januar 2017

Sist bekreftet

1. januar 2017

Mer informasjon

Begreper knyttet til denne studien

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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