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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027731
Receipt No. 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

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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
Email 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
Email saito-k@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031774

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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