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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Alessandro Napoli, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01693770
First received: September 20, 2012
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Secondary Malignant Neoplasm of Bone
Procedure: MRgFUS
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Primary Pain Palliation and Local Tumor Control in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Patients will be monitored for major or minor adverse events


Secondary Outcome Measures:
  • To correlate the treatment response to extent of tumor necrosis as determined by follow-up imaging [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    necrosis of the actual lesion will be analyzed according to area on non-perfused volume at the end of the procedure


Enrollment: 18
Study Start Date: January 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693770

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

No publications provided

Responsible Party: Alessandro Napoli, MD, PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01693770     History of Changes
Other Study ID Numbers: BM-MRgFUS
Study First Received: September 20, 2012
Last Updated: June 17, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2014