UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009782 |
|---|---|
| Receipt number | R000011454 |
| Scientific Title | Evaluation of the severity of chylothorax and the localization of the leakage site of chyle by three-dimensional thoracic duct scintigraphy |
| Date of disclosure of the study information | 2013/03/14 |
| Last modified on | 2021/02/10 12:13:15 |
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Basic information
Public title
Evaluation of the severity of chylothorax and the localization of the leakage site of chyle by three-dimensional thoracic duct scintigraphy
Acronym
Validation of three-dimensional thoracic duct scintigraphy
Scientific Title
Evaluation of the severity of chylothorax and the localization of the leakage site of chyle by three-dimensional thoracic duct scintigraphy
Scientific Title:Acronym
Validation of three-dimensional thoracic duct scintigraphy
Region
| Japan |
Condition
Condition
Chylothorax
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of the three-dimensional thoracic duct scintigraphy using orally-administered I-123 15-(4-iodophenyl)-3(R,S)-methylpentadecanoic acid (BMIPP) and single Photon Emission Tomography (SPECT)/CT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To correlate the parameters of 3D-thoracic duct scintigraphy and subsequently-increased amount of chylous pleural effusion.
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
| Behavior,custom |
Interventions/Control_1
Three-dimensitonal thoracic duct scintigraphy using orally-administered 15-(4-iodophenyl)-3(R,S)-methylpentadecanoic acid (BMIPP)and single Photon Emission Tomography (SPECT)/CT
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 Diagnosis of chylothorax by thoracentesis regardless of a history of surgery
2 Fair ggeneral condition (PS below 2)
No history of heart disease.
3 There is written consent of the patient.
Key exclusion criteria
1 Under 20 year old
2 Lactating or pregnant women
3 With dysphagia
4 Previous participation of clinical trials
etc.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Takanami |
Organization
Tohoku University Hospital
Division name
Department of Radiology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7312
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 Radiology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7312
Homepage URL
takanami@rad.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Research grant from Japan Radiological Society supported by Bayer
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2013 | Year | 03 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 15 | 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
| 2013 | Year | 01 | Month | 15 | Day |
Last modified on
| 2021 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011454
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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