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MRI Guided HIFU for Palliation of Painful Skeletal Metastases in Children

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ClinicalTrials.gov Identifier: NCT02616016
Recruitment Status : Recruiting
First Posted : November 26, 2015
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
James Drake, The Hospital for Sick Children

Brief Summary:
The Philips Sonalleve MR-HIFU system is expected to be effective in reducing pain intensity and/or reducing analgesic use in patients with painful uncomplicated bone metastases. No serious adverse effects are expected to result from this treatment.

Condition or disease Intervention/treatment Phase
Bone Metastases Pain Device: MRI Guided High Intensity Focused Ultrasound Not Applicable

Detailed Description:
The objective of this study is to determine if MR-guided high intensity focused ultrasound (MR-HIFU) is an effective technique for alleviating the pain associated with bone metastases in paediatric cancer patients. This technique meant to be an adjunct therapy to the standard-of-care, which includes radiation therapy and chemotherapy. Safety of the technique will be assessed through evaluating non-targeted heating using MRI-based temperature mapping, and inspecting patients post-treatment for skin burns. or other signs of serious adverse events. Efficacy of the technique will be assessed by evaluating/recording patients observed pain, quality of life, and pain medication usage both before and up to 3 months following treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases in Children - A Pilot Study
Study Start Date : April 2014
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
MRI guided High Intensity Focused Ultrasound Treatment

Intervention Group The interventional radiologist will locate the target tissue and mark the volume to be treated using MRI images.

The operator starts the treatment and monitors the progress of the treatment with MR thermal and dose maps to ensure adherence to treatment plan.

An individual treatment sonication will last approximately 30 seconds.

Device: MRI Guided High Intensity Focused Ultrasound
Target treatment of bone metastases using High Intensity Focused Ultrasound




Primary Outcome Measures :
  1. Change in pain intensity scores from baseline as measured on pain diaries. [ Time Frame: 2, 7, 14, 30 and 90 days following treatment ]
    As measured on the pain diaries before and at day 2, 7, 14, 30 and 90 days following treatment.


Secondary Outcome Measures :
  1. Improved patient quality of life after MR-HIFU using a quality of life questionnaire. [ Time Frame: 2, 7, 14, 30 and 90 days post treatment ]
    Using age appropriate quality of life questionnaire that involves interviewing patient and/or parent/guardian before and 2, 7, 14, 30 and 90 days post treatment.



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • able to give informed consent
  • weight <140 kg (requirement to fit safely on top of the HIFU table and inside MRI
  • any radiologic evidence of bone metastases from any solid tumor (neuroblastoma, osteosarcoma, soft tissue sarcoma, or any other solid tumor metastases).
  • pain specifically at the site of interest (target lesion)
  • pain score for target lesion >/ = 4 (indicating at least moderate pain) on an age-appropriate 0-10 point scale
  • Target lesion in uncomplicated (ie no fracture / spinal cord compression /cauda equine syndrome/ soft tissue component)
  • Available 3D MRI image of the target lesion (or be able to obtain one in a clinically feasible amount of time as part of the baseline investigational stage.)
  • Proposed MR-HIFU treatment date >/= 2 weeks from most recent treatment of target tumour or systems chemotherapy
  • Proposed MR-HIFU treatment date >/= 1 week after administration of steroids for pain flare

Exclusion Criteria:

  • Unable to characterize pain specifically at the site of interest (target lesion).
  • Pregnant / nursing females
  • Target lesion is complicated (ie pressure of one fracture /spinal cord compression/cauda equine 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 HIIFU beam path or at site of target lesion.
  • Active infection.
  • Contradiction to general anesthesia or or gadolinium MRI contrast agent.
  • Requirement for general anaesthesia for non -HIFU related MRI scans.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616016


Contacts
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Contact: James M Drake, FRCSC,FACS 416-813-6125 james.drake@sickkids.ca
Contact: Maria Lamberti-Pasculli, RN 416-813-6456 maria.lamberti-pasculli@sickkids.ca

Locations
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Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: James M Drake, FRCSC,FACS    416-813-6125    james.drake@sickkids.ca   
Contact: Maria Lamberti-Pasculli, RN    416-813-6456    maria.lamberti-pasculli@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: James M Drake, FRCSC,FACS The Hospital for Sick Children
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Responsible Party: James Drake, Neurosurgeon, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02616016    
Other Study ID Numbers: 1000040604
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes