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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 : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Matthew Bucknor, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Osteoid Osteoma Device: MRgFUS Device: CTgRFA Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study to Compare the Effectiveness of Magnetic Resonance Guided Focused Ultrasound With Computed Tomography Guided Radiofrequency Ablation for Treatment of Osteoid Osteomas
Study Start Date : November 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Active Comparator: MRgFUS
Magnetic resonance-guided focused ultrasound ablation
Device: MRgFUS
Magnetic resonance-guided focused ultrasound ablation of osteoid osteoma

Active Comparator: CTgRFA
Computed tomography-guided radiofrequency ablation
Device: CTgRFA
Computed tomography-guided radiofrequency ablation of osteoid osteoma




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Procedure time [ Time Frame: Treatment day ]
    On the day of the treatment, the procedure time will be recorded

  2. Patient preference [ Time Frame: 2 weeks ]
    2 weeks after treatment, patient preference surveys will be assessed

  3. Patient quality of life [ Time Frame: 1 month ]
    1 month after treatment, patient quality of life surveys will be assessed

  4. 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

  5. Adverse events [ Time Frame: 1 month ]
    All adverse events occurring within the first month will be recorded at 1 month following the procedure

  6. 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



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men and women ages ≥ 10 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.

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): NCT02923011


Contacts
Contact: Melanie Regan melanie.regan@ucsf.edu

Locations
United States, California
Stanford Medical Center Recruiting
Palo Alto, California, United States, 94305
Contact: Krithika Rupnarayan       krupnara@stanford.edu   
Principal Investigator: Pejman Ghanouni, MD, PhD         
UCSF Imaging Center Recruiting
San Francisco, California, United States, 94107
Contact: Melanie Regan       melanie.regan@ucsf.edu   
Principal Investigator: Matthew Bucknor, MD         
Sponsors and Collaborators
Matthew Bucknor

Responsible Party: Matthew Bucknor, Assistant Professor in Residence, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02923011     History of Changes
Other Study ID Numbers: FUS513
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

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