NCT01586273

Multicenter Study of Magnetic Resonance-guided High Intensity Focused Ultrasound for Pain Palliation of Bone Metastases

Magnetic Resonance-guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Philips Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) device for treating painful bone metastases.

Detailed description

Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) is a non-invasive outpatient modality. In MR-HIFU, a specially designed ultrasound transducer is used to focus a beam of ultrasound energy into a small volume at a specific target site in the body. The focused beam is intended to produce therapeutic hyperthermia in the target field while only harmlessly warming the immediately surrounding tissue. Magnetic Resonance Imaging is used during the ultrasound treatment, both to focus the ultrasound beam on the target field and to perform real-time thermal mapping at and around the target. The Philips Sonalleve MR-HIFU system is expected to be efficacious in reducing pain scores in patients with painful bone metastases and in reducing their pain medication usage.

Conditions

• Bone Metastasis

Interventions

Type	Name	Description
DEVICE	MR-HIFU treatment for pain palliation of bone metastases	A treatment session with the Philips Sonalleve MR-HIFU device for bone pain palliation with high-intensity focused ultrasound.

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-09-01
• Completion: 2016-11-01
• First posted: 2012-04-26
• Last updated: 2017-04-04

Locations

3 sites across 3 countries: Netherlands, South Korea, United Kingdom