Actively Recruiting
Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
Led by City of Hope Medical Center · Updated on 2025-09-17
24
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent and assent if appropriate
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Pathologic diagnosis of cancer
- Painful bone metastases from any solid cancer with pain score of at least 2 on a 0-10 scale
- Concurrent treatment allowed for up to 3 radiation fields
- Standardized uptake value maximum (SUVmax) of target bone lesions on diagnostic PET greater than 6
- Target bone lesion size between 1.5 and 5 cm
- Pre-screening confirms treatment can be given within dose constraints
- Brain metastases treated prior to enrollment with stable MRI findings 3 months after treatment
- Life expectancy of 6 months or more
- Off systemic therapy for at least one week before and one week after study treatment
- Able to complete pain and quality of life assessments without cognitive impairment
You will not qualify if you...
- Prior radiation therapy to the treatment sites
- Untreated spinal cord compression
- Pathologic fracture at the evaluated site
- Serious medical conditions preventing radiotherapy
- Unable to undergo PET/CT scan
- Pregnant or breastfeeding women
- Investigator judgement of unsuitability or inability to comply with study procedures
- Cognitive impairments preventing completion of study assessments or questionnaires
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
Research Team
Y
Yi-Jen Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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