NCT05250687

MR Guided Focused Ultrasound vs Radiotherapy for Palliative Pain Tx in Bone Metastases

MR Guided Focused Ultrasound Versus Radiotherapy for Palliative Pain Treatment in Patients With Bone Metastases

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-center, randomized study directly comparing outcomes after MR guided high intensity focused ultrasound (MR HIFU) or external beam radiation therapy (EBRT) treatment of painful bone metastases.

Detailed description

The primary purpose of this study is to see if MR guided high intensity focused ultrasound (MR-HIFU) treats bone pain faster than the standard radiation therapy (External beam radiation therapy: EBRT) and to evaluate the patient's pain experience 14 days after completion of the treatment. The secondary purpose is to evaluate the outcomes of the pain, side effects, and quality of life and survival in the first 6 months after treatment.

Conditions

• Bone Metastases

Interventions

Type	Name	Description
PROCEDURE	MR- High intensity focused ultrasound	The intervention treatment is MR-HIFU, which will be given as a standalone treatment. MRHIFU treatment will be delivered using the ExAblate 2100 System (INSIGHTEC, Tirat Carmel, Israel), which is an FDA-approved device for pain palliation of bone metastasesThe ExAblate focused ultrasound device operates in conjunction with an MRI machine. Gadavist is being administered intraveneously as contrast medium for MRI.
RADIATION	External beam radiotherapy	Standard of care for pain palliation of bone metastases consists of single fraction external beam radiotherapy of 8-16 Gray (Gy) or a multi-fraction regime of 20 Gy in 5 fractions, 24 Gy in 6 fractions or 30 Gy in 10 fractions. The radiation schedule is at the discretion of the treating radiation oncologist.

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-02-22
• Last updated: 2024-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study