Biology-Guided Radiation Therapy for the Treatment of Patients with Bone Metastases

Inclusion Criteria

• Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines
• Age: ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Pathologic diagnosis of cancer
• Painful bone metastases from any solid cancers (i.e., a score of at least 2 on a 0-10 scale, 0 representing no pain and 10 representing maximum pain)
• Concurrent treatment of up to 3 radiation fields is allowed
• Standardized uptake value maximum (SUVmax) of the target bone lesions on diagnostic PET > 6
• Size of the target bone lesion 1.5-5 cm
• Pre-screening assessment confirms that the intervention can be administered without exceeding dose constraint guidelines
• Patients with brain metastases can be included but brain metastases must be treated prior to enrollment and follow up magnetic resonance imaging (MRI) 3 months after treatment shows stable findings
• Life expectancy ≥ 6 months in the opinion of the treating investigators
• Off systemic therapy for at least one week prior and one week after study intervention
• Patients able to complete pain assessment and quality of life surveys who do not have cognitive impairment

Exclusion Criteria

• Patients with prior radiation therapy to the treatment sites
• Untreated spinal cord compression
• Pathologic fracture at the evaluated site
• Serious medical comorbidities precluding radiotherapy
• Unable to undergo a PET/CT scan
• Pregnant and/or breastfeeding women are excluded from this study as these agents may have the potential for teratogenic or abortifacient effects
• Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics, patients who exhibit cognitive impairments/ who are unable to complete study materials: assessments/questionnaires)