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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Magnetic resonance-guided focused ultrasound ablation of osteoid osteoma
Computed tomography-guided radiofrequency ablation of osteoid osteoma
Stanford Medical Center
Palo Alto, California, United States
RECRUITINGUCSF Imaging Center
San Francisco, California, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGRate of resolution of pain (worst visual analog scale score over last 24 hours < 2.0)
1 month after treatment, worst VAS score over the last 24 hours will be assessed
Time frame: 1 month
Procedure time
On the day of the treatment, the procedure time will be recorded
Time frame: Treatment day
Patient preference
2 weeks after treatment, patient preference surveys will be assessed
Time frame: 2 weeks
Patient quality of life
1 month after treatment, patient quality of life surveys will be assessed
Time frame: 1 month
Medication use
Self reported medication use for 5 days before, five days after, and 1 month after the treatment
Time frame: 5 days before, five days after, 1 month after
Adverse events
All adverse events occurring within the first month will be recorded at 1 month following the procedure
Time frame: 1 month
Worst VAS
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
Time frame: First 5 days, 1 week, 2 weeks, 3 weeks, 1 month, 6 months, 12 months
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