Primary Pain Palliation in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Primary Pain Palliation and Local Tumor Control in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound|
- To evaluate the safety and efficacy of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the primary treatment of painful bone metastases [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Patients will be monitored for major or minor adverse events
- To correlate the treatment response to extent of tumor necrosis as determined by follow-up imaging [ Time Frame: 6 months ] [ Designated as safety issue: No ]necrosis of the actual lesion will be analyzed according to area on non-perfused volume at the end of the procedure
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
High intensity focused ultrasound energy, delivered under the guidance of the MR images (MgFUS) allows for a predefined amount of energy to be delivered in the desired target (Metastasis). Bone readily absorbs focused ultrasound energy resulting in a thermo-related neurolysis of the periostium with consequent pain palliation. The amount of energy delivered can be modulated with the objective to penetrate cortical space and obtain necrosis of the metastasis thus preventing local recurrence.
Focused ultrasound energy is accumulated into the target tissue (skeletal metastasis) thanks to the real time guidance of the MR images.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693770
|Policlinico Umberto I|
|Rome, Italy, 00100|
|Principal Investigator:||Alessandro Napoli, MD, PhD||Department of Radiological Sciences, Sapienza University of Rome|