NCT05524064

FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Varian, a Siemens Healthineers Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess toxicities of FLASH radiotherapy treatment and pain relief in subjects with painful thoracic bone metastases. FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.

Detailed description

This clinical investigation is designed to assess the toxicities of FLASH radiotherapy treatment, as well as pain relief when used to treat bone metastasis(-es) in the thorax. Workflow metrics of FLASH radiotherapy in the thorax in a clinical setting will also be assessed. Patients at least 18 years of age with painful bone metastases located in the thorax will be considered for the study. Eligible subjects will be treated for painful bone metastases in the thorax using a palliative regimen of FLASH radiotherapy and followed post-treatment until subject death or lost to follow-up.

Conditions

• Bone Metastases in the Thorax

Interventions

Type	Name	Description
RADIATION	FLASH Radiotherapy	A dose of 8 Gy delivered in a single fraction will be prescribed to the PTV, delivered with FLASH Radiotherapy (\>40 Gy/s).

Timeline

• Start date: 2023-03-08
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2022-09-01
• Last updated: 2025-05-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study