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| Name | Class |
|---|---|
| Focused Ultrasound Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRgFUS | Active Comparator | Magnetic resonance-guided focused ultrasound ablation |
|
| CTgRFA | Active Comparator | Computed tomography-guided radiofrequency ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRgFUS | Device | Magnetic resonance-guided focused ultrasound ablation of osteoid osteoma |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate 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 | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time | On the day of the treatment, the procedure time will be recorded | Treatment day |
| Patient preference | 2 weeks after treatment, patient preference surveys will be assessed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Aslam | Contact | maya.aslam@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Bucknor, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Medical Center | Recruiting | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D010017 | Osteoma, Osteoid |
| ID | Term |
|---|---|
| D010016 | Osteoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| CTgRFA |
| Device |
Computed tomography-guided radiofrequency ablation of osteoid osteoma |
|
| 2 weeks |
| Patient quality of life | 1 month after treatment, patient quality of life surveys will be assessed | 1 month |
| Medication use | Self reported medication use for 5 days before, five days after, and 1 month after the treatment | 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 | 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 | First 5 days, 1 week, 2 weeks, 3 weeks, 1 month, 6 months, 12 months |
| UCSF Imaging Center | Recruiting | San Francisco | California | 94107 | United States |
|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |