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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000017532
Receipt No. 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

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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
Email 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
Email ryuta@nsg.med.tohoku.ac.jp

Sponsor
Institute Department of Neurosurgery, Tohoku University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020320

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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