ENROLL

Osteoid osteoma is a benign, but painful, bone tumor commonly occurring in children and young adults. Osteoid osteoma treatment options include surgical excision or, more commonly, CT-guided radiofrequency ablation. Osteoid osteoma treatment with radiofrequency ablation is less invasive than surgery, but still requires drilling from the skin through muscle and soft tissue into bone in order to ablate the osteoid osteoma. It also exposes the patient and operator to ionizing radiation from CT guidance.

Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) provides precise and controlled delivery of heat to ablate the osteoid osteoma using an external ultrasound probe, without the need for a scalpel, bone drill, or needle.

MR-HIFU ablation of osteoid osteoma may provide a better alternative to surgical resection or radiofrequency ablation as it is completely non-invasive and does not require ionizing radiation. These two qualities of MR-HIFU are especially beneficial for growing children and young adults. Furthermore, MR-HIFU treatment is quick, with expected procedure time of less than two hours. Such short treatments offer additional safety benefits from reduced anesthesia / sedation requirement compared to surgery and radiofrequency ablation.

The following images show MR-HIFU treatments from two patients in our first clinical trial:

At Children’s National Hospital, we completed the first prospective clinical trial of osteoid osteoma ablation using MR-HIFU in the U.S. This trial showed that the treatment of osteoid osteoma refractory to medical therapy can be performed safely in patients. Complete pain relief without any medication was achieved within one week of treatment in most patients and was also accompanied by improved quality of life. We are now enrolling for larger trial evaluating efficacy of MR-HIFU for the ablation of painful osteoid osteoma in children and young adults (ClinicalTrials.gov Identifier NCT04658771). Patients less than 30 years of age with painful osteoid osteoma may be eligible to enroll.

Study Goals

• To evaluate safety and efficacy of MR-HIFU ablation for painful osteoid osteoma in children and young adults.

Eligibility

Features and Benefits

• Completely non-invasive treatment
• No ionizing radiation
• Precise MRI-based therapy planning and real-time temperature monitoring
• Immediate verification of treatment success
• Permanent relief of osteoid osteoma pain

For more information, please contact

• Clinical Trial Coordinator
  • Ann Liew, MS, CCRP
  • aliew@childrensnational.org | 202-476-2021

• Principal Investigator
  • Karun V. Sharma, MD, PhD
  • KVSharma@Childrensnational.org | 202-476-1283

ENROLL

Background and Motivation

• Osteoid Osteoma is a benign, but painful, bone tumor commonly occurring in children and young adults.
• Common treatment options are surgical excision or, more recently, CT-guided radiofrequency ablation. Radiofrequency ablation is less invasive, but it still requires drilling from the skin through muscle and soft tissue into bone. It also exposes the patient and operator to ionizing radiation.
• Magnetic resonance-guided high intensity focused ultrasound (MR-HIFU) ablation of osteoid osteoma may provide a better alternative to surgical resection or radiofrequency ablation as it is completely non-invasive and does not require ionizing radiation. These two qualities of MR-HIFU are especially beneficial in growing children and young adults.
• Furthermore, MR-HIFU osteoid osteoma ablation is quick, with expected total procedure time of less than two hours. Such short treatments offer additional safety benefits from reduced anesthesia / sedation requirement compared to surgery and radiofrequency ablation.