An interventional study of simulation-free, single-fraction palliative radiation therapy in Bone Metastases, sponsored by University of Utah. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by University of Utah · Not applicable, Interventional, and Treatment
The goal of this study is to provide proof that patients can be treated with simulation-free, single-fraction palliative radiation therapy with a single in-person visit.
University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants must adhere to the following sex and contraceptive/barrier requirements:
For participants of non-child bearing potential: The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). The following age-specific requirements apply:
\< 50 years of age:
Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
---≥ 50 years of age:
Exclusion Criteria:
Radiation: simulation-free, single-fraction palliative radiation therapy
Radiation will be delivered in a single fraction. The recommended prescription dose is 8 Gy with external beam radiation therapy. Up to two sites of bone metastases may be treated on trial (i.e. no more than two radiation portals). Each site may have multiple lesions.
To assess the rate at which the intervention is delivered with fidelity to protocol.
To provide proof-of-concept that patients can be treated with simulation-free, single-fraction palliative radiation therapy with only a single in-person visit to Huntsman Cancer Hospital (HCH). This will be defined as receiving simulation-free, single-fraction radiation therapy with documented real-time approval by the radiation oncologist, medical physicist, and radiation therapist that the treatment adequately covers the target without unreasonable or unsafe differences.
Time frame: 1 day
The percentage of patients who experience an improved Functional Assessment of Cancer Therapy Quality of Life Measurement in patients with bone pain score at 30 days post-treatment compared to baseline.
To assess whether the percentage of patients who experience an improvement in patient-reported quality of life related to bone pain after simulation-free, single-fraction palliative radiation therapy is consistent with a historical standard of 70%. Improved will be defined as an increase in total FACT-BP score of ≥ 2.
Time frame: 30 days
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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