UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017532 |
|---|---|
| Receipt number | R000020320 |
| Scientific Title | Confirmation and verification of usefulness of methionine positron emission tomography for brain and spinal cord tumors. |
| Date of disclosure of the study information | 2015/05/12 |
| Last modified on | 2018/08/28 10:07:27 |
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Basic information
Public title
Confirmation and verification of usefulness of methionine positron emission tomography for brain and spinal cord tumors.
Acronym
Methionine PET for brain and spinal cord tumors
Scientific Title
Confirmation and verification of usefulness of methionine positron emission tomography for brain and spinal cord tumors.
Scientific Title:Acronym
Methionine PET for brain and spinal cord tumors
Region
| Japan |
Condition
Condition
Brain and spinal cord tumors
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This non-randomized single arm study is designed to confirm the usefulness of 11C-methionine (MET) positron emission tomography (PET) for diagnosis of brain and spinal cord tumors. Diagnostic accuracy will be the primary outcome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy compared to the histological diagnosis.
Key secondary outcomes
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
| Medicine | Device,equipment |
Interventions/Control_1
1. 11C will be prepared with the cyclotron at Tohoku University Hospital. Methionine will be synthesized and examined in the hot laboratory.
2. Synthesized methionine will be given intravenously to the patients in the PET imaging facility of Radiology department. Patients will then be subjected to PET/CT scanning.
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) Cases diagnosed as brain or spinal cord tumors with other methodologies such as CT and /or MRI. Cases with brain or spinal cord tumors with suspected recurrence after treatment.
2) Patients with operable systemic conditions.
3) Though with consciousness disturbances and/or neurological deficits, patients with operable systemic conditions will be eligible.
4) Informed consent taken from the patient. In case it is difficult to get the signature of patient due to neurological deficits, representative person may sign as long as patient is able to understand and give his approval.
Key exclusion criteria
1) Patients without brain or spinal cord lesions.
2) Patients whose systemic condition not able to tolerate the surgical intervention.
3) Patients unable to give the approval.
4) Women in pregnancy or breast feeding women.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiko Sonoda |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai
TEL
022-717-7230
sono@nsg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuta Saito |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai
TEL
022-717-7230
Homepage URL
ryuta@nsg.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 12 | 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
Suspended
Date of protocol fixation
| 2015 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 12 | Day |
Last modified on
| 2018 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020320
