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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027712
Receipt No. R000031745
Scientific Title Validation study of 3D-thoracic duct scintigraphy by orally administered 123I BMIPP with healthy subjects.
Date of disclosure of the study information 2017/06/14
Last modified on 2017/06/14

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Basic information
Public title Validation study of 3D-thoracic duct scintigraphy by orally administered 123I BMIPP with healthy subjects.
Acronym Validation study of 3D-thoracic duct scintigraphy
Scientific Title Validation study of 3D-thoracic duct scintigraphy by orally administered 123I BMIPP with healthy subjects.
Scientific Title:Acronym Validation study of 3D-thoracic duct scintigraphy
Region
Japan

Condition
Condition Chylothorax
Classification by specialty
Surgery in general Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to validate the three-dimensional (3D) thoracic duct scintigraphy using orally-administered I-123 BMIPP for the visualization of thoracic duct as a basis study for the clinical application for chylothorax.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of the time the drug passes through the stomach after administration of radiopharmaceutical, the time until the thoracic duct is depicted, and the time until the systemic circulation is visualized.
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
Medicine
Interventions/Control_1 After orally administeration of radioactive pharmaceuticals, I-123 BMIPP, drug dynamics is tracked with a gamma camera.
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 (1)Currently not visiting a hospital
(2)No history of chest and abdominal surgery
(3)Male and female aged 20 years and over when acquiring consent
(4)Accept written oral and written explanation about participation in research and agree on written agreement
Key exclusion criteria (1)Difficulty fasting from the night inspection the day before
(2)Allergic to iodine or milk
(3)Severe back pain
(4)Possible pregnancy, during pregnancy, within 28 days after birth, or nursing
(5)Aspiration, impaired passage of gastrointestinal tract
(6)Difficult to climb up and down stairs
(7)Mental psychosis or psychiatric symptoms
(8)Judging undesirable as the subject of this study by the doctor
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Takanami
Organization Tohoku University Hospital
Division name Department of Diagnostic Radiology
Zip code
Address 1-1 Seiryo-cho, Aoba-ku, Miyagi, Japan
TEL 022-717-7312
Email takanami@rad.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Takanami
Organization Tohoku University Hospital
Division name Department of Diagnostic Radiology
Zip code
Address 1-1 Seiryo-cho, Aoba-ku, Miyagi, Japan
TEL 022-717-7312
Homepage URL
Email takanami@rad.med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
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 14 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 09 Day
Last modified on
2017 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031745

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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