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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018485
Receipt No. R000021401
Scientific Title An effectiveness of arterial spin labeling perfusion MRI combined with contrast MRI for determination of tumor typess
Date of disclosure of the study information 2015/09/01
Last modified on 2020/02/07

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Basic information
Public title An effectiveness of arterial spin labeling perfusion MRI combined with contrast MRI for determination of tumor typess
Acronym An effectiveness of arterial spin labeling perfusion MRI combined with contrast MRI for determination of tumor typess
Scientific Title An effectiveness of arterial spin labeling perfusion MRI combined with contrast MRI for determination of tumor typess
Scientific Title:Acronym An effectiveness of arterial spin labeling perfusion MRI combined with contrast MRI for determination of tumor typess
Region
Japan

Condition
Condition Metastatic brain tumor
Glioma
Lymphoma
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility of non-contrast perfusion MRI(ASL) for differentiating diagnosis of brain tumors in comparison with DSC-MRI by quantitative evaluation in patients with brain tumors
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Non-Inferiority of diagnostic concordance among high grade glioma, Lymphoma and Metastasis by ASL-MRI in comparison with DSC-MRI.
Key secondary outcomes 1. Relationship between category based on discrepancy between ASL imaging and enhanced MR imaging, histological findings of brain tumors.
1. Category : "ASL dominant", and "CE dominant"
2. Diagnostic performance of recurrence and radionecrosis (in primary tumors) by ASL-MRI (Sensitivity, Specificity, PPV, NPV by quantitative evaluation)
3. Relationship between ASL(CBF ) and DSC(CBV, CBF, MTT, Tmax) parameters.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 contrast-enhanced MRI
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.Adult (20 years old or older)
2.Patients with brain tumor suspected (including necrosis, recurrence)
3.Written informed consent is obtained.
Key exclusion criteria Patients who meet any of the following criteria are not eligible for the study:
1.Contraindication of MRI exam. Patients who have a heart pacemaker, cochlear implant, metallic foreign body, metallic devices
2.Patients who have history of hypersensitivity for Gd contrast media
3.Patients with severe CKD(eGFR<30mL/min/m2)
4.Pregnancy
5.Any others judged ineligible as a subject by the investigator
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Masafumi
Middle name
Last name Harada
Organization Tokushima University
Division name Institute of Biomedical Sciences, School of Medicine
Zip code 770-8509
Address 3-18-15, Kuramoto-cho, Tokushima city, Tokushima 770-8509
TEL 088-633-9283
Email masafumi@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Abe
Organization Tokushima University
Division name Institute of Biomedical Sciences, School of Medicine
Zip code 770-8509
Address 3-18-15, Kuramoto-cho, Tokushima city, Tokushima 770-8509
TEL 088-633-9283
Homepage URL
Email abe.takashi@tokushima-u.ac.jp

Sponsor
Institute Tokushima 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 Tokushima University
Address 3-18-15, Kuramoto-cho, Tokushima city, Tokushima 770-8509
Tel 088-631-3111
Email abe.takashi@tokushima-u.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
2015 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 100
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason There is a problem with the analysis and the planned analysis is not completed.
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
2015 Year 05 Month 20 Day
Date of IRB
2015 Year 08 Month 31 Day
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 30 Day
Last modified on
2020 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021401

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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