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

NCT01693770 | Unknown Phase 1 DMC

• 1 other identifier: BM-MRgFUS
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Malignant Neoplasm of Bone

Keywords

Bone Metastasis; Pain Palliation; High Intensity Focused Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To correlate the treatment response to extent of tumor necrosis as determined by follow-up imaging

  6 months

Study Arms (1)

MRgFUS

OTHER

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

Interventions

MRgFUS PROCEDURE

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

Also known as: MRgFUS, ExAblate, InSightec, MR-HIFU, Magnetic Resonance-guided Focused Ultrasound

MRgFUS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Policlinico Umberto I

Rome, Rome, 00100, Italy

Location

Study Officials

• Alessandro Napoli, MD, PhD

  Department of Radiological Sciences, Sapienza University of Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: September 26, 2012
• Study Start: January 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 18, 2014

Record last verified: 2014-06

Locations

IT (1)