- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03086824
A Safety Evaluation of MR-guided Focused Ultrasound Treatment for Palliative Pain Control of Bone Metastases
16. marts 2017 opdateret af: Jo-Ting Tsai, Taipei Medical University Shuang Ho Hospital
The purpose of this study is to investigate the safety and effectiveness of subjects receiving MR-guided Focused Ultrasound (MRgFUS) treatment for painful bone metastases.
This study will evaluate treatment response and clinically significant adverse events.
Other relevant data may be documented as well.
Studieoversigt
Status
Ukendt
Intervention / Behandling
Detaljeret beskrivelse
This proposed study will be performed in full compliance with all applicable privacy rules and regulations, and their implementations at participating site(s).
All subjects planned to undergo the MRgFUS procedure at Taipei Medical University Hospital will be offered informed consent so they can be included in this Study.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
20
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Taipei, Taiwan, 110
- Department of Radiation Oncology, Taipei Medical University 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
20 år til 99 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Men and women age 20 and older.
- Patients who are able and willing to give consent and able to attend all study visits.
- Patients who are suffering from symptoms of bone metastases: Patients who have received radiation without adequate relief from metastatic bone pain as determined by the patient and treating physician, those for whom their treating physician would not prescribe radiation or additional radiation treatments, and those patients who refuse additional radiation therapy.
- Patient with NRS (0-10 scale) pain score ≥ 4 irrespective of medication.
- Targeted bone/tumor interface are ExAblate device accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3-L5), Sacral vertebra (S1-S5).
- Patient whose targeted lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin.
- Targeted (treated) tumor clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible.
- Patients on ongoing chemotherapy regimen at the time of eligibility: 1) with same chemotherapy regimen (as documented from patient medical dossier, 2) worst pain NRS still ≥ 4, and 3) do NOT plan to initiate a new chemotherapy for pain palliation should be eligible for the study. Note: Planned multiple courses of chemotherapy are not considered New Chemotherapy.
- No radiation therapy to targeted (most painful) lesion in the past two weeks.
- Bisphosphonate intake should remain stable throughout the study duration. -
Exclusion Criteria:
- Patients who either Need surgical stabilization of the affected bony structure or Targeted tumor is at an impending fracture site or Surgical stabilization of tumor site with metallic hardware.
- KPS (Karnofsky performance scale) Score < 60.
- Unable to communicate sensations during the ExAblate treatment.
- Target (treated) tumor is less then 10-mm from nerve bundles, bowels or bladder.
- Patients with acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
- Severe cerebrovascular disease (multiple CVA or CVA within 6 months).
- Patients with unstable cardiac status (e.g. unstable angina pectoris, myocardial infarction within 6 months, congestive heart failure NYHA Class IV, on arrhythmic drugs).
- Severe hypertension (diastolic BP > 100 mmHg on medication).
- Patients on dialysis.
- Patients with standard contraindications for MRI or MRI contrast agents. -
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: MRgFUS
Patients with painful bone metastases receiving magnetic resonance-guided focused ultrasound treatment.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Treated-related Adverse Events
Tidsramme: 12-months
|
12-months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change from baseline Quality of Life Questionnaire
Tidsramme: 1day, 3days, 1-week, 2-weeks, 1-month, 2-months, 3-months, 6-months, 9-months, 12-months
|
1day, 3days, 1-week, 2-weeks, 1-month, 2-months, 3-months, 6-months, 9-months, 12-months
|
Change from baseline Pain Score
Tidsramme: 1day, 3days, 1-week, 2-weeks, 1-month, 2-months, 3-months, 6-months, 9-months, 12-months
|
1day, 3days, 1-week, 2-weeks, 1-month, 2-months, 3-months, 6-months, 9-months, 12-months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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 (Faktiske)
12. december 2014
Primær færdiggørelse (Forventet)
1. december 2017
Datoer for studieregistrering
Først indsendt
7. december 2016
Først indsendt, der opfyldte QC-kriterier
16. marts 2017
Først opslået (Faktiske)
22. marts 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. marts 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. marts 2017
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TMU-SHH-2014-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
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 magnetic resonance-guided focused ultrasound
-
Institute of Cancer Research, United KingdomAfsluttetLivmoderhalskræft | Livmoderhalskræft | Vulva kræft | Endometriecancer | Vaginal kræft | LivmoderkræftDet Forenede Kongerige
-
Institute of Cancer Research, United KingdomPhilips Medical SystemsAfsluttet
-
Institute of Cancer Research, United KingdomCancer Research UK; Philips Medical SystemsTrukket tilbageKræft | KnoglemetastaserDet Forenede Kongerige
-
Washington University School of MedicineTrukket tilbageLokalt avanceret livmoderhalskræft
-
Matthew BucknorFocused Ultrasound Foundation; InSightec-TxSonicsRekrutteringUdifferentieret Pleomorphic SarkomForenede Stater
-
The Hospital for Sick ChildrenSunnybrook Health Sciences CentreAfsluttetSmerte | Osteoid Osteom | Godartet knogletumorCanada
-
Sunnybrook Health Sciences CentreSunnybrook Research Institute; Arrayus Technologies Inc.Aktiv, ikke rekrutterende
-
Nader SanaiInSightec; SonALAsense, Inc.; Barrow Neurological Institute; Ivy Brain Tumor...RekrutteringGliom af høj kvalitetForenede Stater
-
Ohio State UniversityIkke rekrutterer endnuAngst | Medicin-refraktær Fokal-debut epilepsiForenede Stater
-
SonALAsense, Inc.Aktiv, ikke rekrutterendeTilbagevendende GBMForenede Stater