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

NCT ID: NCT01693770

Last Updated: 2014-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-02-28

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

MRgFUS

Intervention Type: PROCEDURE

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

Interventions

MRgFUS

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

Intervention Type: PROCEDURE

Other Intervention Names

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

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Alessandro Napoli

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandro Napoli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiological Sciences, Sapienza University of Rome

Locations

Policlinico Umberto I

Rome, Rome, Italy

Countries

Italy

Other Identifiers

BM-MRgFUS

Identifier Type: -

Identifier Source: org_study_id