UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009017 |
|---|---|
| Receipt number | R000010579 |
| Scientific Title | C-11-Methionine-PET/CT evaluation of the occurrence of local recurrence and metastasis, and assessment of the prognosis regarding brain tumor, orbital tumor and head and neck region cancer treated by carbon ion radiotherapy |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2012/10/01 18:17:24 |
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Basic information
Public title
C-11-Methionine-PET/CT evaluation of the occurrence of local recurrence and metastasis, and assessment of the prognosis regarding brain tumor, orbital tumor and head and neck region cancer treated by carbon ion radiotherapy
Acronym
Head and neck region methionine PET/CT clinical study
Scientific Title
C-11-Methionine-PET/CT evaluation of the occurrence of local recurrence and metastasis, and assessment of the prognosis regarding brain tumor, orbital tumor and head and neck region cancer treated by carbon ion radiotherapy
Scientific Title:Acronym
Head and neck region methionine PET/CT clinical study
Region
| Japan |
Condition
Condition
Brain tumor, orbital tumor, head and neck region cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether or not prediction of the occurrence of local recurrence and metastasis as well as prognosis is possible regarding patients with brain tumor, orbital tumor and head and neck region cancer treated by carbon ion radiotherapy using C-11-Methionine PET/CT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tracer uptake in Methionine PET/CT study, occurrence of local recurrence and metastasis, and patient prognosis
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
C-11-Methionine PET/CT, FDG-PET/CT if necessary
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
Brain tumor, orbital tumor and head and neck region cancer patients planned for carbon ion radiotherapy
Key exclusion criteria
Patients regarded as unsuitable by responsible investigators
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyosan Yoshikawa |
Organization
National Institute of Radiological Sciences
Division name
Research center for charged particle therapy
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba 263-8555, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Institute of Radiological Sciences
Division name
Research center for charged particle therapy
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba 263-8555, Japan
TEL
043-206-3350
Homepage URL
kyo_yosi@nirs.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 02 | 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
| 2012 | Year | 10 | Month | 01 | Day |
Last modified on
| 2012 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010579
