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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001965
Receipt No. R000002395
Scientific Title The evaluation study of clinical potentials using 320-row detector computed tomography (Aquilion ONE).
Date of disclosure of the study information 2009/09/01
Last modified on 2017/04/24

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Basic information
Public title The evaluation study of clinical potentials using 320-row detector computed tomography (Aquilion ONE).
Acronym The evaluation study of clinical potentials for area detector CT.
Scientific Title The evaluation study of clinical potentials using 320-row detector computed tomography (Aquilion ONE).
Scientific Title:Acronym The evaluation study of clinical potentials for area detector CT.
Region
Japan

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

Objectives
Narrative objectives1 We aim at doing a clinical evaluation study of 320-row of newest area detector computed tomography (Aquilion ONE).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of 320-row area detector computed tomography in the image diagnosis of a malignant tumor.
Key secondary outcomes Development of the new image-diagnosis procedure based on fourth dimension image data.

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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Evaluation of pre-operative diagnosis for malignant tumor using 320-raw ADCT in the National Cancer Center Hospital East
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 1)The patient of whom it was diagnosed as a malignant tumor and the therapy in the National Cancer Center Hospital East was expected.
2)The patient by whom consent was acquired at the main point of this study.
Key exclusion criteria 1)A patient has the history of the allergy to the contrast materials for computed tomography.
2)The patient by whom consent was not acquired at the main point of this study.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuo Satake
Organization National Cancer Center Hospital East
Division name Division of Radiology
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
TEL 04-7133-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsushi Kobayashi
Organization National Cancer Center Hospital East
Division name Division of Radiology
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
TEL 04-7133-1111
Homepage URL
Email takobaya@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization The Health and Labour Sciences Research Grants for Comprehensive Control Research for Cancer.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2009 Year 09 Month 01 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 Completed
Date of protocol fixation
2009 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 05 Month 13 Day
Last modified on
2017 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002395

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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