UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032217
Receipt No. 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 2018/07/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email e2koda@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 11 Day
Last follow-up date
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
2018 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036364

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.