UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017546 |
|---|---|
| Receipt number | R000020328 |
| Scientific Title | Abdominal and pelvic CEST imaging: quantitative assessment of tissue function, tumor characteristic, tumor aggressiveness |
| Date of disclosure of the study information | 2015/05/13 |
| Last modified on | 2016/11/12 11:01:29 |
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Basic information
Public title
Abdominal and pelvic CEST imaging: quantitative assessment of tissue function, tumor characteristic, tumor aggressiveness
Acronym
Abdominal and pelvic CEST imaging: quantitative assessment of tissue function, tumor characteristic, tumor aggressiveness
Scientific Title
Abdominal and pelvic CEST imaging: quantitative assessment of tissue function, tumor characteristic, tumor aggressiveness
Scientific Title:Acronym
Abdominal and pelvic CEST imaging: quantitative assessment of tissue function, tumor characteristic, tumor aggressiveness
Region
| Japan |
Condition
Condition
Normal tissues and malignant tumors of liver, pancreas, kidney, uterus, prostate and GI
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate function of abdominal tissues, aggressiveness and histological characteristics of malignant tumors using CEST imaging
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of CEST effects between tumor and non-tumor region.
Assessment of diagnostic capability of tumor aggressiveness and histological characteristics by radiological-histological correlation.
Key secondary outcomes
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
| Other |
Interventions/Control_1
With or without CEST imaging
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
MRI was performed for the evaluation abdominal or pelvic tumor.
Informed consent was obtained.
Equal or more than 20 years old
Key exclusion criteria
Contraindication of MRI
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Honda |
Organization
Kyushu University
Division name
Department of Clinical Radiology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka City
TEL
092-642-5695
honda@radiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihisa Takayama |
Organization
Kyushu University
Division name
Department of Clinical Radiology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka City
TEL
092-642-5695
Homepage URL
ytaka@radiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
| 2015 | Year | 05 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
There was a significant difference in APTSIs between GS of 6 and GS of 7, and GS of 7 and GS of 9, but no significant differences in APTSI between GS of 6 and GS of 8, GS of 6 and GS of 9, and GS of 7 and GS of 8. The increase The APTSI in GS of 7 was the highest. The APT-MRI has a possibility as a new biomarker of Pca aggressiveness.
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
| 2012 | Year | 10 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 13 | Day |
Last modified on
| 2016 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020328
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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