UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018485 |
|---|---|
| Receipt number | 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 00:37:55 |
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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
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
abe.takashi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021401
