UMIN-CTR Clinical Trial

Basic information
Public title	Detection of recurrence after radiation therapy using C-11 methionine PET
Acronym	Detection of recurrence after radiation therapy using C-11 methionine PET
Scientific Title	Detection of recurrence after radiation therapy using C-11 methionine PET
Scientific Title:Acronym	Detection of recurrence after radiation therapy using C-11 methionine PET
Region	Japan

Condition
Condition	Primary or secoundary brain tumor, Tumor of the neighboring organ
Classification by specialty	Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We evaluate the usefulness of C-11 methionine comparing with F-18 FDG. C-11 methionine will be prepared using a methionine synthesizer (C-MET100).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Superiority of the sensitivity of C-11 methionine PETover that of F-18 FDG
Key secondary outcomes	"Efficacy: (1) Agreement between the histopathology result and C-11 methionine PET result and F-18 FDG (2) Positive-predictive value (PPV) of C-11 methionine PET (3) The number of cases that treatment strategy was changed from medical treatment to surgical or radiotherapy. (4) PET imaging agreement rate between readers of third party interpretation Committee Safety: Adverse event "

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	Device,equipment
Interventions/Control_1	PET
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) The patients with suspected recurrence of tumor more than a half year after radiation theray (2) The patients that enough diagnosis information is not obtained by the common imaging (CT, MRI) (3) The patients or the patients that a written agreement is obtained about participation of this study by legal representative "
Key exclusion criteria	"(1) The patients with a history of hypersensitivity for C-11 methionine or F-18 FDG. (2) A pregnant woman, nursing mother and the women who may be pregnant (3) The patients who participate in other trials (4) The patients who receive C-11 methioine PET within 90 days (5) The patients whom it is assumed overall status to have difficulty in application of the surgical treatment (6) The patients whom brain metastasis appeared outside of radiation fields (7) The patients that a primary tumor and other metastases caused exacerbation for a metastatic brain tumor remarkably (8) The patients whom it was multiple, and metastasis appeared for a primary cerebral tumor any place other than fields (9) When it is multiple, and a lesion with suspected recurrence of tumor develops independently than three places outside in fields or fields (10) In addition, the patients whom a study person in charge judged to be inadequate as subjects "
Target sample size	99

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Tohru Shiga
Organization	Hokkaido University Hospital
Division name	Depertment of Nuclear Medicine
Zip code
Address	N15W7, Kita-ku, Sapporo, Hokkaido, Japan, 0608638
TEL	011-706-5152
Email	tshiga@med.hokudai.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Coordination Secretariat
Organization	Hokkaido University Graduate School of Medicine
Division name	Depertment of Nuclear Medicine
Zip code
Address	N15W7, Kita-ku, Sapporo, Hokkaido, Japan, 0608638
TEL	011-706-5152
Homepage URL
Email	tshiga@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	1.Osaka University Hospital 2.Fukushima Medical University Hospital
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	大阪大学医学部附属病院（大坂府） 福島県立医科大学附属病院（福島県）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 08 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	Terminated
Date of protocol fixation	2014 Year 12 Month 25 Day
Date of IRB	2019 Year 03 Month 07 Day
Anticipated trial start date	2015 Year 01 Month 12 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 01 Month 06 Day
Last modified on	2019 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018672