Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas

Официальное название

Phase III Study to Compare the Effectiveness of Magnetic Resonance Guided Focused Ultrasound With Computed Tomography Guided Radiofrequency Ablation for Treatment of Osteoid Osteomas

Обзор

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.

Вмешательства

• Устройство MRgFUS
  Magnetic resonance-guided focused ultrasound ablation of osteoid osteoma
• Устройство CTgRFA
  Computed tomography-guided radiofrequency ablation of osteoid osteoma

Первичные конечные точки

• Rate of resolution of pain (worst visual analog scale score over last 24 hours < 2.0) [Срок оценки: 1 month]

Вторичные конечные точки (6)

• Procedure time [Срок оценки: Treatment day]
• Patient preference [Срок оценки: 2 weeks]
• Patient quality of life [Срок оценки: 1 month]
• Medication use [Срок оценки: 5 days before, five days after, 1 month after]
• Adverse events [Срок оценки: 1 month]
• Worst VAS [Срок оценки: First 5 days, 1 week, 2 weeks, 3 weeks, 1 month, 6 months, 12 months]

Критерии участия

Критерии включения

• Men and women ages ≥ 8 years old.
• 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.
• 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.
• 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.
• Patients (or guardians/parents) who are able and willing to give consent (or assent where applicable) and able to attend all study visits.
• No prior interventional therapy for the osteoid osteoma.
• Able to safely undergo MRI exam, tolerate being in an MRI scanner, and receive anesthesia/sedation for the treatment.
• 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.
• Targeted lesion must be deeper than 1 cm from the skin.
• Targeted lesion must be clearly visible by non-contrast MRI.
• Karnofsky Performance Status > 60.

Критерии исключения

• 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.
• Targeted tumor in the skull/spine.
• Targeted tumor is < 1 cm from a major nerve.
• Pregnancy.
• Patients with an acute medical condition (e.g. pneumonia, sepsis) that is expected to hinder them from completing this study.
• 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).
• Severe hypertension (diastolic BP > 100 on medication)
• Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices.
• Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
• Severe cerebrovascular disease.
• Known intolerance or allergy to medications used for sedation/anesthesia.
• Known intolerance or allergy to MR contrast agent (gadolinium chelates).
• Patients unable to communicate with the investigator and staff.
• Patients with persistent pain undistinguishable from the target lesion.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Stanford Medical Center — Palo Alto
• UCSF Imaging Center — San Francisco
• Mayo Clinic — Rochester

Идентификаторы

NCT: NCT02923011 · FUS513

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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