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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014594
Receipt No. R000016979
Scientific Title Optimization of the scan timing after Gd contrast media injection in the detection of brain metastases-Multicenter study-
Date of disclosure of the study information 2014/09/01
Last modified on 2020/01/21

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Basic information
Public title Optimization of the scan timing after Gd contrast media injection in the detection of brain metastases-Multicenter study-
Acronym The optimal interval after Gd injection for MRI of brain metastases
Scientific Title Optimization of the scan timing after Gd contrast media injection in the detection of brain metastases-Multicenter study-
Scientific Title:Acronym The optimal interval after Gd injection for MRI of brain metastases
Region
Japan

Condition
Condition Brain metastases
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the optimal timing of image acquisition for the detection of lesions by retrospectively reviewing contrast-enhanced MRI images of metastatic brain tumors and by assessing changes in the lesion detection rate and in the signal intensity ratio against the surrounding brain parenchyma in function of the latency time between injection and imaging.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes The detection rate of metastatic brain tumor by subjective evaluation of images
Key secondary outcomes The signal intensity ratio of metastatic brain tumor against the surrounding brain parenchyma

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 Patients who meet all the following criteria can be included in the study
1) Patients who had undergone Gd-enhanced brain MRI in the past 3 years (dose: 0.1 mmol/kg)
2) Patients who had undergone contrast-enhanced T1-weighted SE images more than once
3) The time between injection of contrast agent and imaging can be estimated by minutes
4) Lesion size: 3 to 20 mm
5) Both inpatient and outpatient
6) Aged 20 years or older
Key exclusion criteria Patients who meet any of the following criteria are not eligible for the study
1) Patients with bleeding that may affect measurement of the signal intensity
2) The signal intensity cannot be measured
3) Patients with 10 or more lesions
4) Patients who have already enrolled in the present study
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Aoki
Middle name
Last name Shigeki
Organization Juntendo University Hospital
Division name Department of Radiology
Zip code 113-8421
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5802-1230
Email saoki@juntendo.ac.jp

Public contact
Name of contact person
1st name Kouhei
Middle name
Last name Kamiya
Organization The University of Tokyo Hospital
Division name Department of Radiology
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL 03-5800-8666
Homepage URL
Email kkamiya-tky@umin.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University Hospital
Address 113-8421 2-1-1 Hongo, Bunkyo-ku, Tokyo
Tel 03-5802-1230
Email saoki@juntendo.ac.jp

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
2014 Year 09 Month 01 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 490
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 No longer recruiting
Date of protocol fixation
2014 Year 07 Month 08 Day
Date of IRB
2014 Year 05 Month 23 Day
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective observation study

Management information
Registered date
2014 Year 07 Month 18 Day
Last modified on
2020 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016979

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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