UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefllness of hepatic dynamic study using superpara iron oxide with multi-band echoplanar imaging
Title of the study (Brief title)	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	Kazuhiro Saito
Organization	Tokyo Medical University
Division name	Radiology
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	Kazuhiro Saito
Organization	Tokyo Medical University
Division name	Radiology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 04 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	We cannot obtained enough results, because of poor image quality.
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/icdr_e/ctr_view.cgi?recptno=R000031774