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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 nidus . 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 nidus using an external ultrasound probe, without the need for a scalpel or needle. MR-HIFU has been successfully used to treat painful bone metastases in adult clinical trials and one recent report suggests that it can also be used for osteoid osteoma treatment.

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 osteoid osteoma treatment is quick, with expected total procedure time of less than one hour. Such short treatments offer additional safety benefits from reduced anesthesia / sedation requirement compared to surgery and radiofrequency ablation.

At Children’s National, we currently have the first osteoid osteomat treatment trial open for enrollment evaluating the safety and feasibility of MR-HIFU for the ablation of osteoid osteoma (ClinicalTrials.gov Identifier NCT02349971). Patients less than 25 years of age with osteoid osteoma may be eligible to 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 ablationis 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 ablationas 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.
  • We propose the first pediatric clinical trial in the USA of MR-HIFU for the ablation osteoid osteoma

Study Goals

  • To evaluate safety and feasibility of MR-HIFU ablation for osteoid osteoma in children

Eligibility

  • Children and young adults ≤ 25 years of age with osteoid osteoma

Features and Benefits

  • Non-invasive MR-HIFU ablation
  • No ionizing radiation
  • Precise MRI-based therapy planning and execution
  • Real-time temperature imaging in soft tissue
  • Cure of osteoid osteoma and associated pain.

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More Background

 

Osteoid Osteoma is a benign but painful bone tumor that usually affects children in the 5–25 year age range with a ratio of 2:1 males to females. These lesions most commonly occur in the lower extremities and most often involve the cortex of long bones . Osteoid Osteoma releases excess prostaglandins, which produce local vasodilation and inflammatory effects, causing pain. Furthermore, these tumors are characterized by abundant nerve fibers, which amplify the associated pain. The most frequent presenting symptom is localized bone pain that is not associated with trauma or activity. This pain is characteristically worse at night and alleviated by salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs) such as Aspirin and Ibuprofen, which block the arachidonic acid pathway and reduce prostaglandin burden, ultimately leading to pain relief.

For many years, conventional treatment for Osteoid Osteoma has been en bloc surgical resection. Unfortunately, intraoperative localization of the Osteoid Osteoma can be quite difficult as the nidus is not directly visible and surgical removal often requires significant bone resection. Furthermore, in a small percentage of cases, the nidus, which is thought to release the prostaglandins, may be missed during surgery, requiring repeat additional surgery 5. In addition, surgical resection often leads to long recovery periods. Because of these shortcomings, surgical resection has become increasingly less common. Although less invasive surgical techniques using CT guidance have been developed, these methods are still relatively invasive and associated with prolonged recovery times and radiation exposure.

In order to improve on open surgical resection, CT ­guided percutaneous radiofrequency ablation (RFA) was developed as a treatment for Osteoid Osteoma. Since then, RFA is the current standard of care at most US institutions, including CNHS. In this relatively minimally invasive technique, intraprocedural CT imaging is used to accurately guide a bone drill from the skin surface into the bone to the location of the Osteoid Osteoma without the need for any large incisions. Next, a radiofrequency needle probe is placed through the drill into the nidus or center of the Osteoid Osteoma in order to burn/ablate this area. Although RFA is now the most common Osteoid Osteoma treatment method with an 80-98% success rate, there are two main concerns: 1) RFA is still an invasive procedure that requires drilling from the skin through muscle and soft tissue and into bone; and 2) the method exposes the patient and operator to ionizing radiation.

MR-­HIFU has gained popularity around the world since its development as a noninvasive thermal ablation alternative for uterine fibroid and prostate surgery in 2003. Since that time, several applications have been explored and substantiated, including palliative treatment of pain associated with bone metastases. The mechanism for bone pain relief with MR-HIFU involves thermal ablation of periosteal nerves located at the bone surface, which mediate this type of pain. This work recently led one group from Italy to explore the use of MR­-HIFU ablation in treatment of Osteoid Osteoma. In their initial pilot study, six young adult patients with Osteoid Osteoma (mean age 21 years, range 14 – 48 years) were treated using MR­-HIFU with good technical and clinical success and no treatment-related morbidity. These patients remained pain free for six months following treatment. The same group recently published the results of their prospective multicenter trial of MR-HIFU ablation of Osteoid Osteoma in 30 patients in which the mean age was 25 years (range 10-47 years). Based on a complete clinical success rate of 90% without any major adverse events, the authors concluded that MR-HIFU ablation may be an effective and safe treatment of Osteoid Osteoma.

Because of an increased prevalence of Osteoid Osteoma in pediatric patients, and the radiation­-free and non­invasive nature of this treatment modality, evaluation of MR-­HIFU in children is an attractive and logical next step. The rationale for this clinical trial is that, in contrast to currently available treatments, MR-HIFU promises a completely non-invasive Osteoid Osteoma treatment without using ionizing radiation in children. Because of the high acoustic energy absorption properties of cortical bone, MR­-HIFU can ablate periosteal nerves and potentially deposit energy into cortical, and possibly subcortical, Osteoid Osteoma lesions. The favorable acoustic absorption properties of bone coupled with the typically small size of the Osteoid Osteoma nidus should allow for very short treatment times with MR-HIFU. With short ablation times in the range of 1 to 5 minutes and overall treatment times expected to be less than two hours, MR-HIFU would require less time than surgical resection and RFA. Shorter procedure times make MR-HIFU an even more attractive therapy for children, who, unlike adults, all require general anesthesia for treatment.