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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Secondary Malignant Neoplasm of Bone	Procedure: MRgFUS	Phase 1; Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	18 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Primary Pain Palliation and Local Tumor Control in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound
Study Start Date :	January 2011
Estimated Primary Completion Date :	January 2015
Estimated Study Completion Date :	February 2015

Arms and Interventions

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Arm

Intervention/treatment

MRgFUS; 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.

Procedure: MRgFUS; Focused ultrasound energy is accumulated into the target tissue (skeletal metastasis) thanks to the real time guidance of the MR images.; Other Names: MRgFUS, ExAblate, InSightec; MR-HIFU; Magnetic Resonance-guided Focused Ultrasound

Outcome Measures

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Primary Outcome Measures :

1. 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 ]
   Patients will be monitored for major or minor adverse events

Secondary Outcome Measures :

1. To correlate the treatment response to extent of tumor necrosis as determined by follow-up imaging [ Time Frame: 6 months ]
   necrosis of the actual lesion will be analyzed according to area on non-perfused volume at the end of the procedure

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• the presence of a known primary cancer and bone metastases confirmed by two or more imaging modalities;
• exhaustion or refusal of all other pain palliation methods including EBRT;
• confirmation of MRgFUS treatment feasibility at a preliminary MR planning examination (presence of an adequate acoustic window between the transducer, skin and target lesion and absence of bowel loops across the planned ultrasound path)

Exclusion Criteria:

• general contraindication to MR imaging (including pacemaker, ferromagnetic devices or implants)
• general contraindication to gadolinium-based contrast agents (intolerance and/or clinically proven chronic renal failure)
• general contraindication to general/epidural anesthesia or deep sedation

Contacts and Locations

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Locations

Italy
Policlinico Umberto I
Rome, Italy, 00100

Sponsors and Collaborators

University of Roma La Sapienza

Investigators

Principal Investigator:	Alessandro Napoli, MD, PhD	Department of Radiological Sciences, Sapienza University of Rome

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Alessandro Napoli, MD, PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier:	NCT01693770 History of Changes
Other Study ID Numbers:	BM-MRgFUS
First Posted:	September 26, 2012
Last Update Posted:	June 18, 2014
Last Verified:	June 2014

Keywords provided by Alessandro Napoli, University of Roma La Sapienza:

Bone Metastasis; Pain Palliation; High Intensity Focused Ultrasound

Additional relevant MeSH terms:

Neoplasm Metastasis; Neoplasms; Neoplasms, Second Primary; Bone Neoplasms; Bone Marrow Diseases; Neoplastic Processes	Pathologic Processes; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Hematologic Diseases