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

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 Overview

• Status: Unknown
• Conditions: Secondary Malignant Neoplasm of Bone
• Intervention / Treatment: Procedure: MRgFUS

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00100
    • Policlinico Umberto I

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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: MR-HIFU; MRgFUS, ExAblate, InSightec; Magnetic Resonance-guided Focused Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety and efficacy of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the primary treatment of painful bone metastases	Patients will be monitored for major or minor adverse events	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Principal Investigator: Alessandro Napoli, MD, PhD, Department of Radiological Sciences, Sapienza University of Rome

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: September 20, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (Estimate): September 26, 2012

Study Record Updates

• Last Update Posted (Estimate): June 18, 2014
• Last Update Submitted That Met QC Criteria: June 17, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: High Intensity Focused Ultrasound; Bone Metastasis; Pain Palliation
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Musculoskeletal Diseases; Neoplastic Processes; Bone Diseases; Neoplasms; Neoplasm Metastasis; Bone Neoplasms
• Other Study ID Numbers: BM-MRgFUS