UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036364