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Trial record 5 of 4320 for:    bone tumors AND NOT metastatic

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 : Unknown
Verified October 2016 by James Drake, The Hospital for Sick Children.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE November 23, 2015
First Posted Date  ICMJE December 1, 2015
Last Update Posted Date October 14, 2016
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02618369 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MR-Guided High Intensity Focused Ultrasound for Pain Management Of Osteoid Osteoma & Benign Bone Tumors in Children and Adults
Official Title  ICMJE Magnetic Resonance-Guided High Intensity Focused Ultrasound for Pain Management of Osteoid Osteoma and Benign Bone Tumors in Children and Young Adults
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoid Osteoma
  • Benign Bone Tumor
  • Pain
Intervention  ICMJE Device: MR-Guided High Intensity Focused Ultrasound
Target treatment of bone lesion using High Intensity Focused Ultrasound
Study Arms  ICMJE 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.

Intervention: Device: MR-Guided High Intensity Focused Ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 25, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2018
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02618369
Other Study ID Numbers  ICMJE 1000040583
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party James Drake, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE Sunnybrook Health Sciences Centre
Investigators  ICMJE
Principal Investigator: James M Drake, FRCSC, FACS The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP