UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016067
Receipt number R000018671
Scientific Title Dual isotope brain SPECT study with semiconductor SPECT
Date of disclosure of the study information 2015/01/30
Last modified on 2015/06/26 09:45:39

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Basic information

Public title

Dual isotope brain SPECT study with semiconductor SPECT

Acronym

Dual isotpope study with semiconductor SPECT

Scientific Title

Dual isotope brain SPECT study with semiconductor SPECT

Scientific Title:Acronym

Dual isotpope study with semiconductor SPECT

Region

Japan


Condition

Condition

Dementia

Classification by specialty

Neurology Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the quality of dual isotope study using Tc-99m ECD and I-123 DATscan for dementia patients.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To compare dual isotope studies with single isotope studies using semiquantitative analysis.

Key secondary outcomes

To evaluate relationship between findings of DAT iamges and perfusion images.
To evaluate relationship between findings of DAT scan and clinical manifestations.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Period 1/2015 - 10/2016

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

The patients who are informed enough for understanding the aim of this study, and consent to undergoing the tests. However, when the patients cannot comprehend the study aim because of dementia, an attorney can show consent.

Key exclusion criteria

1.The persons who may or do pregnant
2.Nursing persons by breastfeeding
3.The persons with alcohol intolerance
4.The persons with severe renal and hepatic impairment
5.The persons who are administrated the drugs which are supposed to interfere with the DATscan image
6.The persons with claustrophobia
7.The persons with aralgic episode to ECD or DATscan
8.The persons with pacemaker or the device for deep brain stimulation
9.The persons who are estimated inadequate for examinees by the responsible person of this study

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tohoru Shiga

Organization

Hokkaido University Graduate School of Medicine

Division name

Depertment of Nuclear Medicine

Zip code


Address

N15W7, Kita-ku, Sapporo, Hokkaido, Japan, 0608638

TEL

011-706-5152

Email

kakui-s@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tohru Shiga

Organization

Hokkaido University Graduate School of Medicine

Division name

Depertment of Nuclear Medicine

Zip code


Address

N15W7, Kita-ku, Sapporo, Hokkaido, Japan, 0608638

TEL

011-706-5152

Homepage URL


Email

kakui-s@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hokkaido University Graduate School of Medicine

Organization

Division

Category of Funding Organization

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

2015 Year 01 Month 30 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

Enrolling by invitation

Date of protocol fixation

2014 Year 11 Month 18 Day

Date of IRB


Anticipated trial start date

2015 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 12 Month 26 Day

Last modified on

2015 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=R000018671


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name