UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032217 |
|---|---|
| Receipt number | R000036364 |
| Scientific Title | Examination of the mediastinal lymph node using the MRI |
| Date of disclosure of the study information | 2018/04/12 |
| Last modified on | 2020/07/30 09:47:27 |
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Basic information
Public title
Examination of the mediastinal lymph node using the MRI
Acronym
Examination of the mediastinal lymph node using the MRI
Scientific Title
Examination of the mediastinal lymph node using the MRI
Scientific Title:Acronym
Examination of the mediastinal lymph node using the MRI
Region
| Japan |
Condition
Condition
Mediastinal lymphadenopathy
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We examine a utility for benign and malignant differentiation of the lesion using an ADC map level obtained with an MRI image in patients with mediastinal lymphadenopathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) The primary outcome is ADCmap of the MRI in the mediastinal lymph node evaluation and usability of the value.
2) The examination of an ADCmap level and the Erastus graph level obtained under a bronchoscope echo.
3) We examine it whether there are not other useful MRI images.
Key secondary outcomes
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
The patients with plan pathologically diagnosed in surgery and bronchial robustness in the patients that a mediastinal lymph node is enlarged.
20 years old or older
The patients that an agreement is obtained in a document from subjects about study entry.
Key exclusion criteria
MRI is the patient of contraindication
The patients that an agreement is not obtained
The patients that clinical trials responsibility physician or an allotment physician judges participation in this study to be inadequate
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kida Hirotaka |
Organization
St. Marianna University School of Medicine Hospital
Division name
Respiratory internal medicine
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL
044-977-8111
h2kida@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nishimoto Eriko |
Organization
St. Marianna University School of Medicine Hospital
Division name
Respiratory internal medicine
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL
044-977-8111
Homepage URL
e2koda@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
They do not receive the research expenses offer
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
| 2018 | Year | 04 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There is no Important Notice
Management information
Registered date
| 2018 | Year | 04 | Month | 12 | Day |
Last modified on
| 2020 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036364
