UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012441
Receipt number R000012835
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
Date of disclosure of the study information 2013/11/29
Last modified on 2020/12/04 11:35:06

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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 or person

Institute

Department of Orthopaedic Surgery, Kochi
Medical School, Kochi University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012835


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name