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

NCT06549478 | Recruiting Phase 1 DMC

• 3 other identifiers: 23937NCI-2024-06473P30CA033572
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  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.

  Up to 1 year follow-up

• Pain response

  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.

  Up to 1 year follow-up

Secondary Outcomes (4)

• Rates of re-irradiation

  At 1 year follow-up

• Radiographic evidence of disease progression

  Up to 1 year follow-up

• Patient-reported health related quality of life (QOL)

  Up to 1 year follow-up

• Incidence of clinician-related chronic toxic effects

  Up to 1 year follow-up

Study Arms (1)

Treatment (BgRT)

EXPERIMENTAL

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

Procedure: Computed Tomography; Radiation: Image Guided Radiation Therapy; Procedure: Positron Emission Tomography; Other: Questionnaire Administration

Interventions

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (BgRT)

Image Guided Radiation Therapy RADIATION

Undergo BgRT

Also known as: IGRT, image-guided radiation therapy, Image-Guided Radiotherapy

Treatment (BgRT)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Treatment (BgRT)

Questionnaire Administration OTHER

Ancillary studies

Treatment (BgRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Radiotherapy, Image-Guided; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Yi-Jen Chen

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Jen Chen, MD

CONTACT

626-218-4589; yichen@coh.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 12, 2024
• Study Start: July 26, 2024
• Primary Completion (Estimated): January 26, 2027
• Study Completion (Estimated): January 26, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (1)