A Safety Evaluation of MR-guided Focused Ultrasound Treatment for Palliative Pain Control of Bone Metastases

The purpose of this study is to investigate the safety and effectiveness of subjects receiving MR-guided Focused Ultrasound (MRgFUS) treatment for painful bone metastases. This study will evaluate treatment response and clinically significant adverse events. Other relevant data may be documented as well.

Study Overview

• Status: Unknown
• Conditions: Magnetic Resonance Guided Interventional Procedures
• Intervention / Treatment: Device: magnetic resonance-guided focused ultrasound

Detailed Description

This proposed study will be performed in full compliance with all applicable privacy rules and regulations, and their implementations at participating site(s). All subjects planned to undergo the MRgFUS procedure at Taipei Medical University Hospital will be offered informed consent so they can be included in this Study.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Department of Radiation Oncology, Taipei Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men and women age 20 and older.
2. Patients who are able and willing to give consent and able to attend all study visits.
3. Patients who are suffering from symptoms of bone metastases: Patients who have received radiation without adequate relief from metastatic bone pain as determined by the patient and treating physician, those for whom their treating physician would not prescribe radiation or additional radiation treatments, and those patients who refuse additional radiation therapy.
4. Patient with NRS (0-10 scale) pain score ≥ 4 irrespective of medication.
5. Targeted bone/tumor interface are ExAblate device accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3-L5), Sacral vertebra (S1-S5).
6. Patient whose targeted lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin.
7. Targeted (treated) tumor clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible.
8. Patients on ongoing chemotherapy regimen at the time of eligibility: 1) with same chemotherapy regimen (as documented from patient medical dossier, 2) worst pain NRS still ≥ 4, and 3) do NOT plan to initiate a new chemotherapy for pain palliation should be eligible for the study. Note: Planned multiple courses of chemotherapy are not considered New Chemotherapy.
9. No radiation therapy to targeted (most painful) lesion in the past two weeks.
10. Bisphosphonate intake should remain stable throughout the study duration. -

Exclusion Criteria:

1. Patients who either Need surgical stabilization of the affected bony structure or Targeted tumor is at an impending fracture site or Surgical stabilization of tumor site with metallic hardware.
2. KPS (Karnofsky performance scale) Score < 60.
3. Unable to communicate sensations during the ExAblate treatment.
4. Target (treated) tumor is less then 10-mm from nerve bundles, bowels or bladder.
5. Patients with acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
6. Severe cerebrovascular disease (multiple CVA or CVA within 6 months).
7. Patients with unstable cardiac status (e.g. unstable angina pectoris, myocardial infarction within 6 months, congestive heart failure NYHA Class IV, on arrhythmic drugs).
8. Severe hypertension (diastolic BP > 100 mmHg on medication).
9. Patients on dialysis.
10. Patients with standard contraindications for MRI or MRI contrast agents. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRgFUS; Patients with painful bone metastases receiving magnetic resonance-guided focused ultrasound treatment.	Device: magnetic resonance-guided focused ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treated-related Adverse Events	12-months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline Quality of Life Questionnaire	1day, 3days, 1-week, 2-weeks, 1-month, 2-months, 3-months, 6-months, 9-months, 12-months
Change from baseline Pain Score	1day, 3days, 1-week, 2-weeks, 1-month, 2-months, 3-months, 6-months, 9-months, 12-months

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2014
• Primary Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Bone Metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: TMU-SHH-2014-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES