UMIN-CTR Clinical Trial

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033531
Receipt No. R000038234
Official scientific title of the study A study on the usefulness of perfusion CT prescribing the amount of contrast agent by body weight in brain tumor
Date of disclosure of the study information 2018/12/01
Last modified on 2018/07/27 (Ver. 1)

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Basic information
Official scientific title of the study A study on the usefulness of perfusion CT prescribing the amount of contrast agent by body weight in brain tumor
Title of the study (Brief title) A study on the usefulness of perfusion CT prescribing the amount of contrast agent by body weight in brain tumor
Region
Japan

Condition
Condition Brain tumor
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Optimize the amount of contrast medium in perfusion CT by determining the amount of contrast agent according to body weight.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes This study is a retrospective study. In past clinical cases, we narrow down the case of CT perfusion and standard MR perfusion, compare both, and evaluate the usefulness.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Case in which CT perfusion was performed in brain tumor
Key exclusion criteria We will publish this research in opt-out and exclude cases that we could not obtain consent.
Target sample size 50

Research contact person
Name of lead principal investigator Jun Nakane
Organization saitama medical center, saitama medical university
Division name radiology service
Address 1981 Kamoda, Kawagoe, Saitama, 350-8550, JAPAN
TEL 049-228-3518
Email jun_n@saitama-med.ac.jp

Public contact
Name of contact person Jun Nakane
Organization saitama medical center, saitama medical university
Division name radiology service
Address 1981 Kamoda, Kawagoe, Saitama, 350-8550, JAPAN
TEL 049-228-3518
Homepage URL
Email jun_n@saitama-med.ac.jp

Sponsor
Institute saitama medical center, saitama medical 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)

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
2018 Year 12 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 12 Month 01 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Observation test

Management information
Registered date
2018 Year 07 Month 27 Day
Last modified on
2018 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038234