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

Secondary Malignant Neoplasm of Bone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01693770
• Other study ID #: BM-MRgFUS
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• First received: September 20, 2012
• Last updated: June 17, 2014
• Start date: January 2011
• Est. completion date: February 2015

Study information

• Verified date: June 2014
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 18
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Secondary Malignant Neoplasm of Bone

Intervention

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

Locations

Country	Name	City	State
Italy	Policlinico Umberto I	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No