Unique ID issued by UMIN | UMIN000022354 |
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Receipt number | R000025768 |
Scientific Title | Usefulness of using C-11 methionine PET in patient which suspected glioma |
Date of disclosure of the study information | 2016/05/19 |
Last modified on | 2019/05/22 17:49:07 |
Usefulness of using C-11 methionine PET in patient which suspected glioma
Usefulness of using C-11 methionine PET in patient which suspected glioma
Usefulness of using C-11 methionine PET in patient which suspected glioma
Usefulness of using C-11 methionine PET in patient which suspected glioma
Japan |
glioma
Neurosurgery |
Malignancy
NO
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).
Safety,Efficacy
Positive-predictive value (PPV) in the site of negative contrast-enhanced MRI and positive Met-PET which assume a histopathology diagnosis criteria diagnosis.
(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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Device,equipment |
Usefulness of using C-11 methionine PET
Not applicable |
Not applicable |
Male and Female
(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.
(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
90
1st name | |
Middle name | |
Last name | Jun Hatazawa |
Osaka University Hospital
Department of Nuclear Medicine
2-15 Yamadaoka, Suita, Osaka
06-6879-3461
hatazawa@tracer.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Eku Shimosegawa |
Osaka University Hospital
Department of Nuclear Medicine
2-15 Yamadaoka, Suita, Osaka
06-6879-3461
eku@mi.med.osaka-u.ac.jp
Osaka University Hospital
Japan Agency for Medical Research and Development
Japanese Governmental office
YES
UMIN000022067
Hokkaido University Hospital
国立大学法人 大阪大学医学部附属病院
2016 | Year | 05 | Month | 19 | Day |
Unpublished
Completed
2016 | Year | 06 | Month | 27 | Day |
2019 | Year | 04 | Month | 11 | Day |
2017 | Year | 02 | Month | 06 | Day |
2019 | Year | 03 | Month | 31 | Day |
2016 | Year | 05 | Month | 19 | Day |
2019 | Year | 05 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025768
Research Plan | |
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Registered date | File name |
2018/11/20 | HTC-MET-01_試験験実施計画書_第6.01版.pdf |
Research case data specifications | |
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Research case data | |
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