NCT06549478 · City of Hope Medical Center
Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
What this study is about
This clinical trial tests the safety and effectiveness of a single-dose treatment of biology-guided radiation therapy (BgRT) in treating patients with painful cancer that has spread from where it first started (primary site) to the bone (bone metastases). Bone metastases can result in significant pain and reduction in quality of life.
View original scientific description
This clinical trial tests the safety and effectiveness of a single-dose treatment of biology-guided radiation therapy (BgRT) in treating patients with painful cancer that has spread from where it first started (primary site) to the bone (bone metastases). Bone metastases can result in significant pain and reduction in quality of life. Single fraction radiation therapy (SFRT) can produce equivalent pain relief compared to multi-fraction radiation therapy, but SFRT treatments generally lead to higher rates of retreatment. BgRT is a new and innovative form of radiation delivery that uses a signal generated by positron emission tomography to guide external beam radiation therapy. It is a technology breakthrough that uses live, continuously updated data throughout the entire treatment session to determine exactly where to deliver radiotherapy to biologically active tumors. Giving BgRT may be safe and effective in treating patients with painful bone metastases.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Duarte, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 17, 2025 · Source of record for eligibility and locations