Secondary Malignant Neoplasm of Bone Clinical Trial
Official title:
Primary Pain Palliation and Local Tumor Control 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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02887833 -
Thermal Testing in Bone Pain (TiBoP)
|
||
| Completed |
NCT01117246 -
Pilot Study for Palliation of Pain in Bone Metastases by MR-HIFU
|
Phase 1/Phase 2 |