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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000022067
Receipt No. 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

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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
Email 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
Email erisuzu@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025444

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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