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Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases

28. august 2012 opdateret af: Philips Healthcare

Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - A Pilot Study

This study is to confirm the safety and technical of MRI guided High Intensity Focused Ultrasound (HIFU) for Palliation for Pain of Skeletal Metastases.

MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate tissue. The MRI system identifies the ultrasound path and monitors heat rise in the tissue. The goal of the study is to show treatment safety and effectiveness. MR-guided HIFU will be performed in patients who pass inclusion/exclusion criteria.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Bone metastases are common among patients with advanced cancer and have been reported in up to 85% of cancer patients at autopsy. Complications of bone metastases include pain, functional limitation, decreased quality of life, pathological fracture, spinal cord compression and cauda equina syndrome.

External beam radiotherapy is the current standard treatment for patients with painful uncomplicated bone metastases. Unfortunately up to 30 % of patients treated with radiotherapy do not respond to therapy, and 30% of responders have their pain recur at some point after treatment. Radiotherapy re-treatment is also limited by cumulative doses delivered to sensitive structures. Ablative techniques such as cryotherapy and percutaneous radiofrequency ablation are not similarly limited by cumulative effects, however, they are invasive procedures that place patients at risk of complications.

MR-guided high intensity focused ultrasound (MR-HIFU) is a non-invasive, outpatient modality being investigated for the treatment of cancer. In MR-HIFU, a specially designed transducer is used to focus a beam of ultrasound energy into a small volume at a specific target site in the body. The focused beam produces therapeutic hyperthermia in the target field but only harmlessly warms the immediately surrounding tissue. Magnetic resonance (MR) imaging is used both to focus the ultrasound beam on the target field in the bone (the metastatic lesion and adjacent periosteum containing the nerves and vasculature for the tumor) and to perform real-time thermal mapping at and around the target. The mechanism of action of pain response is thought to be thermal periosteal denervation and / or thermal ablation of the tumor mass that diminishes pressure on the surrounding tissue.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age ≥18 years
  • Able to give informed consent
  • Weight <140kg
  • Radiologic evidence of bone metastases from any solid tumor
  • Able to characterize pain specifically at the site of interest (target lesion)
  • Pain score related to target lesion of ≥4 on a 0-10 point scale irrespective of medications
  • Target lesion accessible for MR-HIFU procedure
  • Target lesion maximum dimension ≤8cm
  • Target lesion is uncomplicated (i.e.: no fracture / spinal cord compression / cauda equina syndrome / soft tissue component)
  • Target lesion visible by non-contrast MRI
  • Interface between bone and skin lies ≥1cm from surface
  • Able to communicate sensation during MR-HIFU treatment
  • MR-HIFU treatment date ≥2 weeks from most recent treatment of primary tumor or any chemotherapy.

Exclusion Criteria:

  • Prior radiotherapy / surgery / ablative therapy / other local therapy to target lesion.
  • Unable to characterize pain specifically at the site of interest (target lesion)
  • Pregnant / Nursing woman
  • Target lesion is complicated (i.e.: presence of one of fracture / spinal cord compression / cauda equina syndrome / soft tissue component).
  • Target lesion <1cm from nerve bundles / bladder / bowel
  • Target lesion in contact with hollow viscera
  • Target lesion located in skull, spine (excluding sacrum which is allowed) or sternum
  • Scar along proposed HIFU beam path
  • Orthopaedic implant along proposed HIFU beam path or at site of target lesion.
  • Serious cardiovascular, neurological, renal or hematological chronic disease
  • Active infection
  • Unable to tolerate required stationary position during treatment
  • Allergy to MRI contrast agent or sedation

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: Patients with painful bone metastasis
Patients with bone metastasis causing pain
Enhed: Philips MR-guided HIFU system
HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein and nerve denaturation, irreversible cell damage, and coagulative necrosis.
Andre navne:
  • HIFU
  • Ablation
  • Højintensitetsfokuseret ultralyd

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reduction of Pain Score
Tidsramme: 90 Days
Determine the efficacy of MR-Guided HIFU in reducing pain scores related to the site treated as measured on the Brief Pain Inventory (BPI).
90 Days
Reduction of Pain Medication
Tidsramme: 90 Days
Determine the efficacy of MR-Guided HIFU in reducing pain medication usage
90 Days
Complications and Adverse Events
Tidsramme: 90 Days
Document complications and adverse events as well as the number of unintended lesions that occur as a result of treatment with MR-Guided HIFU.
90 Days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in bone density
Tidsramme: 90 Days
Measure changes in bone density between X-ray and CT images taken prior to and following treatment.
90 Days
Quality of Life
Tidsramme: 90 Days
Measure patient quality of life using both the EORTC QLQ-BM22 and FACT-BP scales
90 Days

Samarbejdspartnere og efterforskere

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

Sponsor

Philips Healthcare

Efterforskere

  • Ledende efterforsker: Greg Czarnota, M.D., Radiation Oncology, Sunnybrook Health Sciences Centre

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.

Generelle publikationer

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 2011

Primær færdiggørelse (Faktiske)

1. juni 2012

Studieafslutning (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først indsendt

2. marts 2011

Først indsendt, der opfyldte QC-kriterier

3. marts 2011

Først opslået (Skøn)

4. marts 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. august 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. august 2012

Sidst verificeret

1. august 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 02082011

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 .

Kliniske forsøg med Philips MR-guided HIFU system

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