Kypho-Intra Operative Radiation Therapy (IORT) for Localized Spine Metastasis, Phase I/II Study

Inclusion Criteria: * Karnofsky Index ≥ 60. * History/physical examination within 4 weeks prior to procedure. * Imaging of the involved spine within 8 weeks prior to procedure to determine the extent of the spine involvement. * Numerical Rating Pain Scale within 4 week prior to procedure (score must be ≥ 5 for at least one of the planned sites for spinal IORT. * Neurological examination within 4 week prior to procedure to rule out rapid neurologic decline. * Spine Instability Neoplastic Score (SINS score) = ≤12. * Negative serum pregnancy test within 4 weeks prior to procedure for women of childbearing potential. * Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control. * The patient must have localized spine metastasis from the T5 to L5 levels by a screening imaging study \[bone scan, PET, CT, or MRI\] (a solitary spine metastasis; two separate spine levels; or up to 3 separate sites are permitted). Each of the separate sites have a maximal involvement of ONE vertebral body. Patients can have other visceral metastasis. * Patients must provide study specific informed consent prior to study entry. Exclusion Criteria: * Spine instability due to a compression fracture; SINS score \>12. * Frank spinal cord compression or displacement or epidural compression within 3 mm of the spinal cord * Patients with rapid neurologic decline * Bony retropulsion causing neurologic abnormality * Patients all…