Back to resultsPrimary Pain Palliation in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound
Primary Purpose
Secondary Malignant Neoplasm of Bone
Status
Unknown status
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
MRgFUS
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Malignant Neoplasm of Bone focused on measuring Bone Metastasis, Pain Palliation, High Intensity 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
Sites / Locations
- Policlinico Umberto I
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MRgFUS
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01693770
First Posted
September 20, 2012
Last Updated
June 17, 2014
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT01693770
Brief Title
Primary Pain Palliation in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound
Official Title
Primary Pain Palliation and Local Tumor Control in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
February 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Malignant Neoplasm of Bone
Keywords
Bone Metastasis, Pain Palliation, High Intensity Focused Ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRgFUS
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
MRgFUS
Other Intervention Name(s)
MRgFUS, ExAblate, InSightec, MR-HIFU, Magnetic Resonance-guided Focused Ultrasound
Intervention Description
Focused ultrasound energy is accumulated into the target tissue (skeletal metastasis) thanks to the real time guidance of the MR images.
Primary Outcome Measure Information:
Title
To evaluate the safety and efficacy of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the primary treatment of painful bone metastases
Description
Patients will be monitored for major or minor adverse events
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To correlate the treatment response to extent of tumor necrosis as determined by follow-up imaging
Description
necrosis of the actual lesion will be analyzed according to area on non-perfused volume at the end of the procedure
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Napoli, MD, PhD
Organizational Affiliation
Department of Radiological Sciences, Sapienza University of Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Umberto I
City
Rome
ZIP/Postal Code
00100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Primary Pain Palliation in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound
We'll reach out to this number within 24 hrs