UMIN-CTR Clinical Trial

Basic information
Public title	Effect of cerebrospinal fluid area mask correction on 123I-FP-CIT SPECT images in idiopathic normal pressure hydrocephalus
Acronym	Effect of cerebrospinal fluid area mask correction on 123I-FP-CIT SPECT images in idiopathic normal pressure hydrocephalus
Scientific Title	Effect of cerebrospinal fluid area mask correction on 123I-FP-CIT SPECT images in idiopathic normal pressure hydrocephalus
Scientific Title:Acronym	Effect of cerebrospinal fluid area mask correction on 123I-FP-CIT SPECT images in idiopathic normal pressure hydrocephalus
Region	Japan

Condition
Condition	idiopathic normal pressure hydrocephalus
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Compared the SBR before and after CSF area mask correction in iNPH using 123I-FP-CIT SPECT and investigated the effect of the correction on the SBR.
Basic objectives2	Others
Basic objectives -Others	Numerical evaluation of SBR in iNPH by 123I-FP-CIT SPECT
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SBR with 123I-FP-CIT SPECT in patients with normal pressure hydrocephalus
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	40 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1)INPH patients tested for MRI and 123I-FP-CIT SPECT 2)Patients with ventricular enlargement with an Evans index of 0.3 or higher on MRI-FLAIR images.
Key exclusion criteria	1)123I-FP-CIT SPECT image-affecting drugs, body movements during examination, organic disorders 2)Those who have withdrawn their consent
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Ohba
Organization	Yamagata University Hospital
Division name	Department of Radiology
Zip code	990-9585
Address	2-2-2 Iida-Nishi, Yamagata
TEL	0236331122
Email	m-ohba@med.id.yamagata-u.ac.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ohba
Organization	Yamagata University Hospital
Division name	Department of Radiology
Zip code	990-9585
Address	2-2-2 Iida-Nishi, Yamagata
TEL	0236331122
Homepage URL
Email	m-ohba@med.id.yamagata-u.ac.jp

Sponsor
Institute	Yamagata University
Institute
Department

Funding Source
Organization	None
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	Ethical Review Committee of Yamagata University Faculty of Medicine
Address	2-2-2 Iida-Nishi, Yamagata
Tel	0236331122
Email	ikekenkyu@jm.kj.yamagata-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

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 11 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	25
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	2014 Year 05 Month 01 Day
Date of IRB	2021 Year 05 Month 30 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2021 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2021 Year 07 Month 11 Day
Last modified on	2021 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051200