UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010237 |
|---|---|
| Receipt number | R000011983 |
| Scientific Title | Positron emission computed tomography (PET) with L-[11C] methionine |
| Date of disclosure of the study information | 2013/03/14 |
| Last modified on | 2013/03/13 17:59:21 |
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Basic information
Public title
Positron emission computed tomography (PET) with L-[11C] methionine
Acronym
PET with methionine
Scientific Title
Positron emission computed tomography (PET) with L-[11C] methionine
Scientific Title:Acronym
PET with methionine
Region
| Japan |
Condition
Condition
malignant tumor
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Breast surgery | Obstetrics and Gynecology |
| Pediatrics | Dermatology | Oto-rhino-laryngology |
| Orthopedics | Urology | Radiology |
| Oral surgery | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of Positron emission tomography using L-[11C] methionin as contrasted with the result of 18 F-FDG PET inspection for diagnosis of various tumors, a heart muscle disease, morbidity evaluation, verification with reference to clinical course and pathologicall diagnosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of diagnosis of various tumor and heart disease
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
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 |
Interventions/Control_1
methionin
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
The patients with malignant tumor and heart disease
Key exclusion criteria
-restless
-extremely poorer health
-pregnant and breast-feeding women
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiyasu Suzuki |
Organization
Yamaguchi University Hospital
Division name
Department of Neurosurgery
Zip code
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Ideguchi |
Organization
Yamaguchi University School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Yamaguchi University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Yamaguchi University School of Medicine
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
| 2013 | Year | 03 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 12 | 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
| 2013 | Year | 03 | Month | 13 | Day |
Last modified on
| 2013 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011983
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
