UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Confirmation and verification of usefulness of methionine positron emission tomography for brain and spinal cord tumors.
Title of the study (Brief title)	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	Yukihiko Sonoda
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Neurosurgery
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	Ryuta Saito
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Neurosurgery
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)

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

Progress
Recruitment status	Suspended
Date of protocol fixation	2015 Year 01 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000020320