The purpose of this study is to assess toxicities of FLASH radiotherapy treatment and pain relief in subjects with painful thoracic bone metastases. FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.
This clinical investigation is designed to assess the toxicities of FLASH radiotherapy treatment, as well as pain relief when used to treat bone metastasis(-es) in the thorax. Workflow metrics of FLASH radiotherapy in the thorax in a clinical setting will also be assessed. Patients at least 18 years of age with painful bone metastases located in the thorax will be considered for the study. Eligible subjects will be treated for painful bone metastases in the thorax using a palliative regimen of FLASH radiotherapy and followed post-treatment until subject death or lost to follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
A dose of 8 Gy delivered in a single fraction will be prescribed to the PTV, delivered with FLASH Radiotherapy (\>40 Gy/s).
OSF Healthcare Saint Francis Medical Center
Peoria, Illinois, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Assessment of radiation-related toxicities that are possibly, probably, or definitely related to FLASH radiotherapy.
Toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. Toxicities will be classified per CTCAE version 5.0.
Time frame: Assessed from start of treatment until 6 months post treatment.
Assessment of pain relief using patient reported pain questionnaire for overall pain score
Patient reported pain overall
Time frame: Change from baseline pain overall at 3 months.
Assessment of pain relief using patient reported pain questionnaire for pain at treated site
Patient reported pain at treated site
Time frame: Change from baseline pain at treated site at 3 months.
Use of pain medication
Capture dose and frequency of pain medication usage or pain medication changes.
Time frame: Change from baseline pain medication usage at 3 months.
Workflow feasibility - time on table
Total subject treatment time on table.
Time frame: Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment.
Workflow feasibility - delays in study treatment
Treatment for an individual subject will be deemed NOT feasible if delays in study treatment of more than 10 business days from simulation to treatment occurs related to the investigational device (excluding delays due to patient or facility factors not related to study treatment).
Time frame: Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment.
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