Back to search results

Biology-Guided Radiation Therapy for Painful Bone Metastases

This clinical trial is testing a new way to deliver radiation therapy called biology-guided radiation therapy (BgRT) for patients with painful cancer that has spread to their bones (bone metastases). BgRT uses signals from a PET scan to guide the radiation. The study aims to see how safe and effective a single treatment of BgRT is at reducing pain. Researchers will also look at your quality of life, any side effects, and if the cancer grows in the treated areas. You may be able to join if you are 18 or older, have a cancer diagnosis, and painful bone metastases from any solid cancer. This study plans to enroll 24 participants.

Study design
This is an interventional study with an enrollment of 24 participants. It is testing a single treatment of biology-guided radiation therapy (BgRT).
What's involved
You would undergo a single BgRT treatment on day 0. You will also have PET/CT scans on study and potentially during follow-up.
Compensation
Not stated in the trial record.
Follow-up
You will be followed up at 2 weeks, 3 months, and then every 3 months for up to 1 year after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06549478

Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases

Recruiting
PHASE1Ages 18+InterventionalTreatment
City of Hope Medical Center
~24 participants
Updated 2025-09-17 on ClinicalTrials.gov
What's tested:Computed TomographyImage Guided Radiation TherapyPositron Emission TomographyQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 1 year follow-up
+1 more outcome measured

Conditions

Metastatic Malignant Neoplasm in the Bone
Metastatic Malignant Solid Neoplasm

Explore related trials

Malignant Bone NeoplasmSolid Neoplasm

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Yi-Jen Chen · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Yi-Jen Chen, MD
[email protected]
626-218-4589
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Incidence of adverse eventsUp to 1 year follow-up

    Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicity is defined as any ≥ grade 3 gastrointestinal, genitourinary, lung, or skeletomuscular toxicities that is considered at least possibly related to the study treatment and occurs within 3 months after the treatment.

  • Pain responseUp to 1 year follow-up

    Will be assessed using international consensus endpoints assessing a combination of pain severity and analgesic consumption. Pain progression reflects either (a) an increase in a worst-pain score of 2 or more without reduced daily morphine milligram equivalent (MME), or (b) no change in worst-pain score or 1 point above baseline and an increase in daily MME of at least 25%. Indeterminate response then indicates all other responses. Overall response is defined as sum of complete response and partial response at 3 months after single fraction-biology-guided radiation therapy.