UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027731 |
|---|---|
| Receipt number | R000031774 |
| Scientific Title | Usefllness of hepatic dynamic study using superpara iron oxide with multi-band echoplanar imaging |
| Date of disclosure of the study information | 2017/06/20 |
| Last modified on | 2018/12/13 09:17:16 |
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Basic information
Public title
Usefllness of hepatic dynamic study using superpara iron oxide with multi-band echoplanar imaging
Acronym
SPIO dynamic study with multi-band echoplanar imaging
Scientific Title
Usefllness of hepatic dynamic study using superpara iron oxide with multi-band echoplanar imaging
Scientific Title:Acronym
SPIO dynamic study with multi-band echoplanar imaging
Region
| Japan |
Condition
Condition
liver tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usfullness of dynamic MRI using superparamagnetic iron oxide with multi-band echoplanar imaging.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the accuracy of the detection of hypervascular liver tumor with multi-band EPI.
Key secondary outcomes
To evaluate the imaging qualitatively.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Equal or abobe 20 years-old
Patients who need SPIO dynamic study, for example due to having the allergy of gadolinium based contrast or asthma.
Suspicion of hepatocellular carcinoma by computed tomography or ultrasound
Patients who are followed up after TACE or RFA
Key exclusion criteria
Having a metal allergy.
Having ulcers in the gastrointestinal tract.
Iron agent is prescribed by anemia.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Saito |
Organization
Tokyo Medical University
Division name
Radiology
Zip code
Address
6-7-1, Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
saito-k@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Saito |
Organization
Tokyo Medical University
Division name
Radiology
Zip code
Address
6-7-1, Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
saito-k@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
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
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
| 2017 | Year | 06 | Month | 20 | 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
We cannot obtained enough results, because of poor image quality.
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
Terminated
Date of protocol fixation
| 2017 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will evaluate the tumor vascularity using SPIO dynamic study. We will use the findings of enhanced ultrasound as gold standard.
Management information
Registered date
| 2017 | Year | 06 | Month | 12 | Day |
Last modified on
| 2018 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031774
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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