Biology-guided radiation therapy for painful bone metastases
A Pilot Study of BgRT for Bone Metastases
This study is testing a new type of radiation therapy to see if it can help people with painful bone cancer feel less pain and improve their quality of life.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT06549478 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of a single-dose biology-guided radiation therapy (BgRT) for patients suffering from painful bone metastases due to cancer. The study aims to assess pain response and quality of life improvements following treatment, utilizing advanced imaging techniques to precisely target biologically active tumors. Participants will receive a single fraction of BgRT and will be monitored for pain relief, quality of life, and any adverse effects over a year. The innovative approach of BgRT allows for real-time adjustments during treatment based on live imaging data.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with painful bone metastases from any solid tumors and a performance status of 0-2.
Not a fit: Patients with non-painful bone metastases or those with untreated brain metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve quality of life for patients with bone metastases.
How similar studies have performed: Other studies have shown promise with similar innovative radiation therapies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Yi-Jen Chen — City of Hope Medical Center
- Study coordinator: Yi-Jen Chen, MD
- Email: yichen@coh.org
- Phone: 626-218-4589
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.