UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011790 |
|---|---|
| Receipt number | R000013784 |
| Scientific Title | Comparison of the usefulness of [11C]4DST-PET/CT and [18F]FDG-PET/CT in the characterization of lung tumor |
| Date of disclosure of the study information | 2013/09/20 |
| Last modified on | 2018/03/22 10:34:44 |
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Basic information
Public title
Comparison of the usefulness of [11C]4DST-PET/CT and [18F]FDG-PET/CT in the characterization of lung tumor
Acronym
[11C]4DST-PET/CT clinical study for lung tumor
Scientific Title
Comparison of the usefulness of [11C]4DST-PET/CT and [18F]FDG-PET/CT in the characterization of lung tumor
Scientific Title:Acronym
[11C]4DST-PET/CT clinical study for lung tumor
Region
| Japan |
Condition
Condition
lung tumor
Classification by specialty
| Chest surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the usefulness of PET/CT using a cellular proliferation probe, [11C]4DST, and a glucose metabolism probe, [18F]FDG, in the characterization of lung tumors, both PET/CT examinations are performed for pre-surgical patients with lung tumors. The role of [11C]4DST and [18F]FDG as a prognostic indicator will be also evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Tumor uptake of [11C]4DST and [18F]FDG
Pathological characterization of resected tumors
Key secondary outcomes
Prognostic information of patients
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
| Medicine |
Interventions/Control_1
[11C]4DST- and [18F]-FDG-PET/CT examinations
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
Lung tumor patients going to be operated with the suspicion of lung cancer
Key exclusion criteria
Patients regarded as unsuitable by responsible investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuneo Saga |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3421
saga@nirs.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuneo Saga |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3421
Homepage URL
saga@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
| 2013 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | 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 | 09 | Month | 18 | Day |
Last modified on
| 2018 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013784
