UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016128 |
|---|---|
| Receipt number | R000018672 |
| Scientific Title | Detection of recurrence after radiation therapy using C-11 methionine PET |
| Date of disclosure of the study information | 2015/01/08 |
| Last modified on | 2019/05/30 15:41:54 |
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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
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
tshiga@med.hokudai.ac.jp
Public contact
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
tshiga@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018672
