UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on differential diagnosis of radiation necrosis and brain tumor recurrence with dual stage Methionine PET/CT
Title of the study (Brief title)	Dual stage Methionine PET/CT
Region	Japan

Condition
Condition	brain tumor recurrence and radiation necrosis
Classification by specialty	Neurology Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To make accuracy, sensitivity, specificity higher by adding delayed image of methionine PET.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Which is more accurate, the conclusion from early image only and the conclusion from both early image and delayed image are compared. The answer is acquired by the course or the pathology.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	patients who undergoes methionine PET/CT to determine whether radiation necrosis or brain tumor recurrence
Key exclusion criteria	patients who do not agree to participate patients who have difficulty in stopping moving other patients whom researcher (doctor) judged to exclude.
Target sample size	40

Research contact person
Name of lead principal investigator	Masashi Kameyama
Organization	National Center for Global Health and Medicine
Division name	Division of Nuclear Medicine
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan, 162-8655
TEL	03-5273-6881
Email	kame-tky@umin.ac.jp

Public contact
Name of contact person	Masashi Kameyama
Organization	National Center for Global Health and Medicine
Division name	Division of Nuclear Medicine
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan, 162-8655
TEL	03-5273-6881
Homepage URL
Email	kame-tky@umin.ac.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization	Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 14 Day
Anticipated trial start date	2014 Year 10 Month 14 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	under observation

Management information
Registered date	2015 Year 08 Month 14 Day
Last modified on	2018 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021594