UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study of Safety and Practicality of Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) treatment for painful bone metastases
Acronym	A study of MRgFUS treatment for painful bone metastases
Scientific Title	A clinical study of Safety and Practicality of Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) treatment for painful bone metastases
Scientific Title:Acronym	A study of 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 safety and practicality of MRgFUS treatment for the palliation of painful bone metastases. Discussion for appropriate cost of MRgFUS.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Improvement of pain score (Time Frame: within 6 months of treatment)
Key secondary outcomes	Improvement in quality of life Changes in image findings of the treatment 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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who are suffuring from symptoms of bone metastases and are not suitable to other accepted available treatments, such as surgery, radiation and chemotherapy, or refuse other altanitive therapy. 2) 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 2points on the NRS compared to the site to be treated.) 3) Targeted tumor size under 8cm in diameter. 4) Patient whose targeted tumor is on bone and is deeper than 10-mm from the skin. 5) Targeted tumor clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible. 6) Able to communicate sensations during the ExAblate treatment. 7) Patients who are able and willing to give consent and able to attend all study visit.
Key exclusion criteria	1) Patients with uncontrolled pain lesion except for targeted tumor. 2) More than 4 painful lesions. 3) Patients with NRS (0-10 scale) pain score <4 irrespective of medication. 4) No radiation therapy or chemotherapy in the past two weeks. 5) Patients with unstability of targeted tumor: -Pathological fracture -Need surgical stabilization in impending fracture. -Patients with surgical stabilization with metallic hard ware. 6) Patients on dialysis. 7) Patients with unstable cardiac status which interfere with daily life. -Unstable angina pectoris on medication. -Patients developed myocardial infarction within six months of protocol entry. -Congestive heart failure requiring medication (other than siuretic). -Any patients disqualified by a study physician because of their cardiac status. 8) Patients with severe hypertension (diastolic BP > 100 on medication). 9) Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight > 113kilograms) and claustrophobia. 10) Known hypersensitivity to the MRI contrast agent (e.g. Magnevist etc.) including advanced kidney disease. 11) Karnofsky Performance Status < 60. 12) Severe cerebrovascular disease (multiple CVA or CVA within 6 months). 13) Individuals who are not able to tolerate prolonged stationary position during treatment (approximately 2 hrs). 14) Patients whose targeted tumor is less than 10-mm from nurve bundle, intestine or bladder. 15) Patients who are participating or have participated in another clinical trial in last 30 days. 16) Patients unable to communicate with the investigator and staff. 17) Pain source unidentifiable. 18) Patients who are pregnant or lactating. 19) Conspicuous prolong of coagulation time (limit to INR>1.5). 20) Any patients disqualified by a study physician or any other reason.
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hirotaka Kawano
Organization	Teikyo University School of Medicine
Division name	Department of Orthopedic Surgery
Zip code
Address	2-11-1 Kaga, Itabashi-ku, Tokyo 173-8601, Japan
TEL	03-3964-1211(32660)
Email	hkawano-tky@umin.net

Public contact
1st name of contact person	1st name Middle name Last name Hirotaka Kawano
Organization	Teikyo University School of Medicine
Division name	Department of Orthopedic Surgery
Zip code
Address	2-11-1 Kaga, Itabashi-ku, Tokyo 173-8601, Japan
TEL	03-3964-1211(32660)
Homepage URL
Email	hkawano-tky@umin.net

Sponsor
Institute	Teikyo University School of Medicine
Institute
Department

Funding Source
Organization	Shintoshin Musashino clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	帝京大学医学部附属病院（東京都）、新都心むさしのクリニック（埼玉県）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Completed
Date of protocol fixation	2017 Year 11 Month 30 Day
Date of IRB	2017 Year 11 Month 30 Day
Anticipated trial start date	2018 Year 01 Month 15 Day
Last follow-up date	2020 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 12 Month 07 Day
Last modified on	2019 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034430