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Primary Pain Palliation and Local Tumor Control in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound

Phase 1/Phase 2
18 Years
90 Years
Open (Enrolling by invite only)
Secondary Malignant Neoplasm of Bone

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Trial Information

Primary Pain Palliation and Local Tumor Control in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound

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.

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

- general contraindication to gadolinium-based contrast agents (intolerance and/or
clinically proven chronic renal failure)

- general contraindication to general/epidural anesthesia or deep sedation

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and efficacy of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the primary treatment of painful bone metastases

Outcome Description:

Patients will be monitored for major or minor adverse events

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Alessandro Napoli, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiological Sciences, Sapienza University of Rome


Italy: Ethics Committee

Study ID:




Start Date:

January 2011

Completion Date:

February 2013

Related Keywords:

  • Secondary Malignant Neoplasm of Bone
  • Bone Metastasis
  • Pain Palliation
  • High Intensity Focused Ultrasound
  • Bone Neoplasms
  • Neoplasms
  • Neoplasm Metastasis
  • Bone Marrow Diseases
  • Neoplasms, Second Primary