UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005096 |
|---|---|
| Receipt number | R000006026 |
| Scientific Title | 11C-methionine PET for diagnoses of lung cancer and lymph node metastases in the mediastinum and pulmonary hilum: probability of prognostic prediction |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2015/10/01 21:11:55 |
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Basic information
Public title
11C-methionine PET for diagnoses of lung cancer and lymph node metastases in the mediastinum and pulmonary hilum: probability of prognostic prediction
Acronym
11C-methionine PET: probability of prognostic prediction in lung cancer
Scientific Title
11C-methionine PET for diagnoses of lung cancer and lymph node metastases in the mediastinum and pulmonary hilum: probability of prognostic prediction
Scientific Title:Acronym
11C-methionine PET: probability of prognostic prediction in lung cancer
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of our study is to evaluate the usefulness of diagnosis and treatment response assessment using 11C-methionine PET-CT in patients with lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The assessment of our study is to calculate SUVmax of primary lesion and lymph node metastasis on 11C-MET-PET, correlating with morphological evaluation using CT and histopathological evaluation.
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
To scan PET-CT after administering intravenously 11C-methionine in patients with lung cancer.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
preoperative patients with lung cancer
Key exclusion criteria
not getting informed consent from patients
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Hatazawa |
Organization
Osaka university graduate school of medicine
Division name
Nuclear medicine
Zip code
Address
2-2, Yamadaoka, Suita, Japan
TEL
06-6879-3461
hatazawa@tracer.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Hatazawa |
Organization
Osaka university graduate school of medicine
Division name
Nuclear medicine
Zip code
Address
2-2, Yamadaoka, Suita, Japan
TEL
06-6879-3461
Homepage URL
hatazawa@tracer.med.osaka-u.ac.jp
Sponsor or person
Institute
The department of nuclear medicine in osaka university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
global COE program
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 03 | 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
Completed
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2013 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 16 | Day |
Last modified on
| 2015 | 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=R000006026
