Actively Recruiting
A Pilot Study of Biology-Guided Radiation Therapy for Painful Bone Metastases
Led by City of Hope Medical Center ยท Updated on 2025-09-17
24
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating biology-guided radiation therapy (BgRT) for patients experiencing painful bone metastases from cancer. This phase 1 clinical trial aims to assess the safety and effectiveness of a single-dose BgRT treatment in reducing pain and improving quality of life for these patients. BgRT is an innovative radiation technique that uses live data from positron emission tomography (PET) scans to precisely target active tumors during treatment. Participants receive a single fraction of BgRT at a dose of 14 gray on day 0. PET/computed tomography (CT) scans are performed during the study and optionally during follow-up. The trial monitors patients over time to track pain response, toxicity, disease progression at treated sites, and rates of re-irradiation. During the study, patients undergo pain and quality of life assessments, imaging scans such as PET/CT and MRI, and clinical evaluations at 2 weeks, 3 months, and then every 3 months up to one year. Researchers collect data on adverse events, patient-reported outcomes, and radiographic evidence to evaluate the treatment's impact and safety over a year-long follow-up period.
CONDITIONS
Brief Title
Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented informed consent from the participant or legally authorized representative
- Age 18 years or older
- ECOG performance status of 0 to 2
- Pathologic diagnosis of cancer
- Painful bone metastases with a pain score of at least 2 on a 0-10 scale
- Concurrent treatment allowed for up to 3 radiation fields
- Target bone lesions with a standardized uptake value maximum (SUVmax) greater than 6 on diagnostic PET
- Target bone lesion size between 1.5 and 5 cm
- Pre-screening confirms treatment can be administered within dose constraints
- Stable brain metastases if present, treated prior to enrollment with stable MRI findings at 3 months
- Life expectancy of at least 6 months
- Off systemic cancer therapy for at least one week before and after study treatment
- Ability 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 treatment site
- Serious medical conditions preventing radiotherapy
- Inability to undergo PET/CT scan
- Pregnancy or breastfeeding
- Investigator judgment that the patient is unsuitable or unlikely to comply with study procedures
- Cognitive impairments preventing completion of study assessments or questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day (Day 0)
Participants receive a single dose of biology-guided radiation therapy (BgRT) for painful bone metastases.
1 treatment visit (in-person)
Duration - Up to 1 year
Participants are monitored for safety, pain response, quality of life, and disease progression after treatment.
Visits at 2 weeks, 3 months, and every 3 months thereafter for up to 1 year
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
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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