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Trial record 15 of 115 for:    focused ultrasound | Recruiting, Not yet recruiting, Available Studies

MR-Guided High Intensity Focused Ultrasound for Pain Management Of Osteoid Osteoma & Benign Bone Tumors in Children and Adults

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ClinicalTrials.gov Identifier: NCT02618369
Recruitment Status : Recruiting
First Posted : December 1, 2015
Last Update Posted : October 14, 2016
Sponsor:
Collaborator:
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
James Drake, The Hospital for Sick Children

Brief Summary:
The Philips Sonalleve HIFU system is expected to be efficacious in reducing pain scores in patients with painful osteoid osteoma and other benign bone tumors, and in reducing their pain medication usage. No serious adverse effects are expected to result from this treatment.

Condition or disease Intervention/treatment Phase
Osteoid Osteoma Benign Bone Tumor Pain Device: MR-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 safe and effective technique for alleviating the pain associated with osteoid osteoma and other benign bone tumors in paediatric patients and adults(up to age 40 yrs). This technique meant to be an alternative to the standard-of-care, radiofrequency and laser-based percutaneous ablation. 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 6 months following treatment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnetic Resonance-Guided High Intensity Focused Ultrasound for Pain Management of Osteoid Osteoma and Benign Bone Tumors in Children and Young Adults
Study Start Date : April 2014
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
MR-HIFU treatment

The interventional radiologist will locate the target lesion 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.

Device: MR-Guided High Intensity Focused Ultrasound
Target treatment of bone lesion using High Intensity Focused Ultrasound




Primary Outcome Measures :
  1. Change in pain intensity scores from baseline related to the site treated target lesion. [ 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 after treatment.


Secondary Outcome Measures :
  1. Reduction in in pain medication usage (NSAIDS, Opioids). [ Time Frame: 2, 7, 14, 30 and 90 days following treatment. ]
    As noted in pain diaries by patient before and day 2, 7. 14, 30 and 90 days after treatment.



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Ages Eligible for Study:   5 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 5-40 years.
  • Able to give informed consent and have parent or guardian give informed consent if applicable.
  • Weight <140 kg (requirement to fit safely on top of the HIFU table and inside the MRI).
  • Definitive radiographic & clinical presentation of osteoid osteoma or other benign tumor lesion(avoiding need for biopsy).
  • Pain specifically at the site of interest target lesion.
  • Pain score for target lesion >/= 4 (indicating at least moderate pain) or an age-appropriate pain scale.
  • Target lesion is uncomplicated (i.e. no fracture/spinal cord compression/cauda equina syndrome/soft tissue component).
  • MR-HIFU treatment date >/= 2 weeks from most recent surgical treatment of lesion.

Exclusion Criteria:

  • Unable to characterize pain specifically at the site of interest (target lesion).
  • Pregnant/nursing females.
  • Target lesion is complicated (i.e. presence of one of fracture/spinal cord compression/cauda equina syndrome/soft tissue component).
  • Target lesion < 1cm from neurovascular bundles/bowel/hollow viscera or regions of cartilage/ bone growth).
  • 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 tissue.
  • Serious cardiovascular, neurological, renal or haematological chronic disease.
  • Active infection.
  • Contraindication to general anaesthetic or gadolinium MRI contrast agent.
  • Requirement for general anesthesia for non-HIFU related MRI's.

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): NCT02618369


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

Locations
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
Principal Investigator: James M Drake, FRCSC, FACS The Hospital for Sick Children

Responsible Party: James Drake, Neurosurgeon, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02618369     History of Changes
Other Study ID Numbers: 1000040583
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by James Drake, The Hospital for Sick Children:
High Intensity Focused Ultrasound

Additional relevant MeSH terms:
Bone Neoplasms
Osteoma
Osteoma, Osteoid
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type