UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study of the Safety and effectiveness of Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) treatment for the palliation of painful bone metastases
Acronym	MRgFUS treatment for painful bone metastases
Scientific Title	A clinical study of the Safety and effectiveness of Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) treatment for the palliation of painful bone metastases
Scientific Title:Acronym	MRgFUS treatment for painful bone metastases
Region	Japan

Condition
Condition	metastatic bone tumor
Classification by specialty	Orthopedics Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and effectiveness of MRgFUS treatment for the palliation of painful bone metastases.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complications and Adverse Events Improvement in Pain scores [Time Frame: within 6 months of treatment]
Key secondary outcomes	Improvement in quality of life Changes in image findings of the treated site [Time Frame: within 6 months of treatment]

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) treatment
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Men and women age 18 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 and are radiation failures: Radiation failure candidates are those 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. Patients who refuse other accepted available treatments such as surgery or narcotics for pain alleviation 5. Patients will have from 1 to 5 painful lesions and only the most painful lesion will be treated. 6. Patient with NRS (0-10 scale) pain score >= 4 irrespective of medication 7. Patients with persistent distinguishable pain associated with 1 site to be treated (if patient has pain from additional sites, the pain from the additional sites must be evaluated as being less intense by at least 2 points on the NRS compared to the site to be treated) 8. Targeted tumor (treated) size up to 55 cm2 in surface area 9. Patient whose targeted (treated) lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin. 10. Targeted (treated) tumor clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible 11. Able to communicate sensations during the ExAblate treatment 12. Patients on ongoing chemotherapy regimen for at least 1 month at the time of eligibility: -with same chemotherapy regimen (as documented from patient medical dossier), And -Worst pain NRS still >= 4, And -do NOT plan to initiate a new chemotherapy for pain palliation should be eligible for the study. 13. No radiation therapy to targeted (most painful) lesion in the past two weeks 14. Bisphosphonate intake should remain stable throughout the study duration.
Key exclusion criteria	1. Patients who either -Need surgical stabilization of the affected bony structure, OR -Targeted tumor is at an impending fracture site, OR -Patients with surgical stabilization of tumor site with metallic hardware 2. More than 5 painful lesions, or more than 1 requiring immediate localized treatment 3. Patients on dialysis 4. Patients with life expectancy < 3-Months 5. Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study 6. Patients with unstable cardiac status including: -Unstable angina pectoris on medication -Patients with documented myocardial infarction within six months of protocol entry -Congestive heart failure requiring medication (other than diuretic) -Patients on anti-arrhythmic drugs 7. Patients with severe hypertension (diastolic BP > 100 on medication) 8. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight >113kilograms), etc. 9. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease 10. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease 11. Karnofsky Performance Status (KPS) Score < 60 12. Severe cerebrovascular disease (multiple CVA or CVA within 6 months) 13. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.) 14. Are participating or have participated in another clinical trial in the last 30 days 15. Patients unable to communicate with the investigator and staff 16. Patients with persistent undistinguishable pain (pain source unidentifiable) 17. Patients who are pregnant or lactating 18. Patients with severe coagulation abnormalities 19. Any patients disqualified by a study physician because of medical, psychological or any other reason
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Motohiro Middle name Last name Kawasaki
Organization	Kochi Medical School, Kochi University
Division name	Department of Orthopaedic Surgery
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku, Kochi 783-805, Japan
TEL	088-880-2386
Email	im35@kochi-u.ac.jp

Public contact
Name of contact person	1st name Motohiro Middle name Last name Kawasaki
Organization	Kochi Medical School, Kochi University
Division name	Department of Orthopaedic Surgery
Zip code	7838505
Address	Kohasu, Oko-cho, Nankoku, Kochi 783-805, Japan
TEL	088-880-2386
Homepage URL
Email	kawasaki-koc@umin.net

Sponsor
Institute	Department of Orthopaedic Surgery, Kochi Medical School, Kochi University
Institute
Department

Funding Source
Organization	Kochi Medical School, Kochi University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kochi Medical School
Address	Kohasu, Oko-cho, Nankoku, Kochi, Jap an
Tel	088-880-2719
Email	im62@kochi-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	高知大学医学部附属病院（高知県）

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 29 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2007 Year 10 Month 15 Day
Date of IRB	2007 Year 10 Month 15 Day
Anticipated trial start date	2007 Year 12 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 11 Month 29 Day
Last modified on	2020 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012835