UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027882
Receipt number R000031950
Scientific Title Development of skeletal muscle evaluation method by 99mTc-MIBI imaging for mitochondrial disease
Date of disclosure of the study information 2017/06/23
Last modified on 2019/06/26 14:18:40

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Basic information

Public title

Development of skeletal muscle evaluation method by 99mTc-MIBI imaging for mitochondrial disease

Acronym

Skeletal muscle evaluation by MIBI for mitochondrial disease

Scientific Title

Development of skeletal muscle evaluation method by 99mTc-MIBI imaging for mitochondrial disease

Scientific Title:Acronym

Skeletal muscle evaluation by MIBI for mitochondrial disease

Region

Japan


Condition

Condition

Mitochondrial disease

Classification by specialty

Neurology Radiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the distribution and degree of skeletal muscle lesion by MIBI imaging in mitochondrial disease and to clarify the relationship between these findings and myopathy symptoms.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Characteristics of skeletal muscle distribution and degree of MIBI in mitochondrial disease

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Twice, two days (First time, half a year to one year later)
99mTc-methoxyisobutylisonitrile (MIBI)370MBq

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Certified case of mitochondrial disease certification criteria

Key exclusion criteria

1.Subjects who are pregnant or breastfeeding
2.Subjects who are judged to be difficult to participate due to psychosis or psychiatric symptoms
3.Subjects who are judged that rest during imaging scan can not be maintained.
4.Subjects judged by doctor as maladaptive.

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Megumi Jinguji

Organization

Kagoshima university hospital

Division name

Radiology

Zip code


Address

8-35-1 Sakuragaoka Kagoshima-shi

TEL

099-275-5417

Email

megu@m.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Megumi Jinguji

Organization

Kagoshima university hospital

Division name

Radiology

Zip code


Address

8-35-1 Sakuragaoka Kagoshima-shi

TEL

099-275-5417

Homepage URL


Email

megu@m.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

Kagoshima university

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Scientific Research (C)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 23 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

Terminated

Date of protocol fixation

2017 Year 06 Month 15 Day

Date of IRB

2017 Year 06 Month 15 Day

Anticipated trial start date

2017 Year 06 Month 23 Day

Last follow-up date

2020 Year 07 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

2017 Year 06 Month 23 Day

Last modified on

2019 Year 06 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031950


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name