UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022067 |
|---|---|
| Receipt number | R000025444 |
| Scientific Title | Usefulness of using C-11 methionine PET in patient which suspected glioma |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2019/05/30 15:41:30 |
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Basic information
Public title
Usefulness of using C-11 methionine PET in patient which suspected glioma
Acronym
Usefulness of using C-11 methionine PET in patient which suspected glioma
Scientific Title
Usefulness of using C-11 methionine PET in patient which suspected glioma
Scientific Title:Acronym
Usefulness of using C-11 methionine PET in patient which suspected glioma
Region
| Japan |
Condition
Condition
glioma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To obtain reliable datafor pharmaceutical approval application, we aim to test whether C-11 methionine PET has additional clinical value to MRI.
C-11 methione will be prepared using a methionine synthesizer(C-MET100).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive-predictive value (PPV) in the site of negative contrast-enhanced MRI and positive Met-PET which assume a histopathology diagnosis criteria diagnosis.
Key secondary outcomes
(1) Rate of cases where Met-PET positive area is equivalent to MRI enhanced area
(2)Rate of cases where tumor exists in the area of MRI-positive and Met-PET-negative findings.
(3)Safety:
Presence/absence and details of the adverse event, including abnormal changes of vital signs and laboratory data.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Usefulness of using C-11 methionine PET
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)The patients whose doctor plans a biopsy or tumor resection and whose tumor is suspected as primary glioma by board-certified diagnostic radiologists and board-certified neurosurgeons based on clinical manifestations, clinical courses, and MRI findings.
(2)The patients who or whose legal representative gave a written informed consent to this study.
Key exclusion criteria
(1)The patients with a history of allergic reaction to C-11 methionine or F-18 FDG.
(2)Pregnant women, breast-feeding women, or women who may be pregnant
(3)The patients who is participating in other trials
(4)The patients who underwent C-11 methionine PET within 90 days
(5)The patients whose overall status is not satisfactory for surgical treatment
(6) The patients who cannot undergo contrast-enhanced MRI
(7) The patients whom investigators judged to be inadequate as candidates
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tohru Shiga |
Organization
Hokkaido University Hospital
Division name
Department of Nuclear Medicine
Zip code
Address
N15,W7,Kita-Ku, Sapporo
TEL
011-706-5152
tamaki@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eriko Suzuki |
Organization
Hokkaido University, Graduate School of Medicine
Division name
Department of Nuclear Medicine
Zip code
Address
N15,W7,Kita-Ku, Sapporo
TEL
011-706-5152
Homepage URL
erisuzu@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
1.Osaka University Hospital
2.Fukushima Medical University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
UMIN000022354
Org. issuing International ID_1
Osaka University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学医学部附属病院
福島県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | 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
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
| 2016 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 26 | Day |
Last modified on
| 2019 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025444
