NCT06549478

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

A Pilot Study of BgRT for Bone Metastases

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate pain response by 14 gray (Gy) single fraction (SF)-BgRT for patients with painful bone metastases. SECONDARY OBJECTIVE: I. To evaluate patient-reported health related quality of life (QOL), clinician-rated toxicity per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0, radiographic evidence of disease progression at treated sites, and rate of re-irradiation. OUTLINE: Patients undergo a single fraction of BgRT on day 0. Patients undergo positron emission tomography (PET)/computed tomography (CT) on study and optionally during follow up. After completion of study treatment, patients are followed up at 2 weeks, 3 months and then every 3 months for up to 1 year.

Conditions

• Metastatic Malignant Neoplasm in the Bone
• Metastatic Malignant Solid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo PET/CT
RADIATION	Image Guided Radiation Therapy	Undergo BgRT
PROCEDURE	Positron Emission Tomography	Undergo PET/CT
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2024-07-26
• Primary completion: 2027-01-26
• Completion: 2027-01-26
• First posted: 2024-08-12
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States