UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001965 |
|---|---|
| Receipt number | 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 22:33:02 |
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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
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
takobaya@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002395
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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