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Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas

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ClinicalTrials.gov Identifier: NCT02923011
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Matthew Bucknor, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE September 30, 2016
First Posted Date  ICMJE October 4, 2016
Last Update Posted Date December 4, 2020
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
Rate of resolution of pain (worst visual analog scale score over last 24 hours < 2.0) [ Time Frame: 1 month ]
1 month after treatment, worst VAS score over the last 24 hours will be assessed
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
  • Procedure time [ Time Frame: Treatment day ]
    On the day of the treatment, the procedure time will be recorded
  • Patient preference [ Time Frame: 2 weeks ]
    2 weeks after treatment, patient preference surveys will be assessed
  • Patient quality of life [ Time Frame: 1 month ]
    1 month after treatment, patient quality of life surveys will be assessed
  • Medication use [ Time Frame: 5 days before, five days after, 1 month after ]
    Self reported medication use for 5 days before, five days after, and 1 month after the treatment
  • Adverse events [ Time Frame: 1 month ]
    All adverse events occurring within the first month will be recorded at 1 month following the procedure
  • Worst VAS [ Time Frame: First 5 days, 1 week, 2 weeks, 3 weeks, 1 month, 6 months, 12 months ]
    Worst VAS over the last 24 hours will be assessed for each of the first 5 days following the treatment and then at 1 week, 2 weeks, 3 weeks, 1 month, 6 months, and 12 months following the 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 Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas
Official Title  ICMJE Phase III Study to Compare the Effectiveness of Magnetic Resonance Guided Focused Ultrasound With Computed Tomography Guided Radiofrequency Ablation for Treatment of Osteoid Osteomas
Brief Summary Osteoid osteomas are painful, benign bone tumors that occur most frequently in young males between ages 10 and 20 years. The goal of the proposed study is based on the premise that MRgFUS is noninferior to CT-guided radiofrequency ablation (CTgRFA), in terms of pain reduction following treatment of osteoid osteomas, and offers possible improvements with regards to 1) post-procedural pain, 2) clinical resource utilization, 3) patient experience, and/or 4) adverse events. The data from the current study would provide clinicians important information in deciding between treatment options for ablation of osteoid osteomas.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoid Osteoma
Intervention  ICMJE
  • Device: MRgFUS
    Magnetic resonance-guided focused ultrasound ablation of osteoid osteoma
  • Device: CTgRFA
    Computed tomography-guided radiofrequency ablation of osteoid osteoma
Study Arms  ICMJE
  • Active Comparator: MRgFUS
    Magnetic resonance-guided focused ultrasound ablation
    Intervention: Device: MRgFUS
  • Active Comparator: CTgRFA
    Computed tomography-guided radiofrequency ablation
    Intervention: Device: CTgRFA
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 3, 2016)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and women ages ≥ 8 years old.
  2. Diagnosis of osteoid osteoma as confirmed when a musculoskeletal radiologist and orthopedic oncologist agree that a patient's imaging and clinical history are most compatible with the diagnosis of osteoid osteoma. A patient referred by a clinician other than orthopedic oncologist will require a clinic visit with an orthopedic oncologist for study inclusion.
  3. Patients must have medically uncontrolled pain from an osteoid osteoma, as defined by pain, which, in the view of the referring orthopedic oncologist significantly interferes with that patient's activities of daily living. Pain may be refractory to management with medications because of inadequate pain control, or because of side effects of the pain medication.
  4. If patients have an additional site of pain, it must be 2 points less severe and distinguishable from the pain at the osteoid osteoma site.
  5. Patients (or guardians/parents) who are able and willing to give consent (or assent where applicable) and able to attend all study visits.
  6. No prior interventional therapy for the osteoid osteoma.
  7. Able to safely undergo MRI exam, tolerate being in an MRI scanner, and receive anesthesia/sedation for the treatment.
  8. Targeted bone/tumor interface is accessible to the ExAblate device and located in a rib, extremity (excluding intra-articular location), pelvis, shoulders (including clavicles), or the sternum.
  9. Targeted lesion must be deeper than 1 cm from the skin.
  10. Targeted lesion must be clearly visible by non-contrast MRI.
  11. Karnofsky Performance Status > 60.

Exclusion Criteria:

  1. Patients a) who need surgical stabilization of the affected bone (elevated fracture risk) or b) whose targeted tumor is at an impending fracture site, as determined by the referring orthopedic oncologist.
  2. Targeted tumor in the skull/spine.
  3. Targeted tumor is < 1 cm from a major nerve.
  4. Pregnancy.
  5. Patients with an acute medical condition (e.g. pneumonia, sepsis) that is expected to hinder them from completing this study.
  6. Patients with unstable cardiac status including: patients on anti-arrhythmic drugs, unstable angina pectoris, documented myocardial infarction within six months of protocol entry, congestive heart failure requiring medication (other than diuretic).
  7. Severe hypertension (diastolic BP > 100 on medication)
  8. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices.
  9. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
  10. Severe cerebrovascular disease.
  11. Known intolerance or allergy to medications used for sedation/anesthesia.
  12. Known intolerance or allergy to MR contrast agent (gadolinium chelates).
  13. Patients unable to communicate with the investigator and staff.
  14. Patients with persistent pain undistinguishable from the target lesion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Maya Aslam maya.aslam@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02923011
Other Study ID Numbers  ICMJE FUS513
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthew Bucknor, University of California, San Francisco
Study Sponsor  ICMJE Matthew Bucknor
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, San Francisco
Verification Date December 2020

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