Recruiting
Phase 1

BgRT

Sponsor:

City of Hope Medical Center

Code:

NCT06549478

Conditions

Metastatic Malignant Neoplasm in the Bone

Metastatic Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Image Guided Radiation Therapy

Positron Emission Tomography

Questionnaire Administration

Study Details

Brief summary:

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

Metastatic Malignant Neoplasm in the Bone

Metastatic Malignant Solid Neoplasm

Study ID

NCT06549478

Start date

Jul 26, 2024

Status verified date

Sep, 2025

Completion date

Jan 26, 2027

Anticipated

Primary completion date

Jan 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (BgRT)

Patients undergo a single fraction of BgRT on day 0. Patients undergo PET/CT on study and optionally during follow up.

Interventions

Computed Tomography

Undergo PET/CT

Image Guided Radiation Therapy

Undergo BgRT

Positron Emission Tomography

Undergo PET/CT

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Incidence of adverse events [ Time Frame: Up to 1 year follow-up ]
  • Pain response [ Time Frame: Up to 1 year follow-up ]

Central Contacts and Locations

Central contacts

Yi-Jen Chen, MD

626-218-4589yichen@coh.org

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Yi-Jen Chen

626-218-4589yichen@coh.org

Principal Investigator:

Yi-Jen Chen

More Information

Sponsor

City of Hope Medical Center

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2025-09-17.