NCT01693770

Primary Pain Palliation in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound

Primary Pain Palliation and Local Tumor Control in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Magnetic Resonance guided Focused Ultrasound (MRgFUS) has demonstrated to be effective for pain control through thermally-induced cell death and periosteal denervation caused by cortical heating relative to acoustic energy absorption. There is also evidence that a high intensity focused ultrasound beam can penetrate through the cortical bone to the medullary space, producing thermal necrosis of cancer tissue. However, little is known about the potential effects of MRgFUS as first line therapeutic modality for pain palliation in skeletal metastases. Our hypothesis sought to assess the clinical performance of MRgFUS primary treatment of painful bone metastases and determine the potential of this technique for local tumor control.

Detailed description

Unlike previous studies, in which patients were enrolled for MRgFUS treatment because of the failure of other therapies, our study will be conducted in patients not previously treated with EBRT to the targeted lesion. This is an important new feature, especially given the advantages of MRgFUS, such as lack of ionizing radiation, the ability to conduct treatment on an outpatient basis and the possibility to repeat the treatment as necessary.

Conditions

• Secondary Malignant Neoplasm of Bone

Interventions

Type	Name	Description
PROCEDURE	MRgFUS	Focused ultrasound energy is accumulated into the target tissue (skeletal metastasis) thanks to the real time guidance of the MR images.

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-01-01
• Completion: 2015-02-01
• First posted: 2012-09-26
• Last updated: 2014-06-18

Locations

1 site across 1 country: Italy