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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005096
Receipt No. 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

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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
Email 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
Email hatazawa@tracer.med.osaka-u.ac.jp

Sponsor
Institute The department of nuclear medicine in osaka university graduate school of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006026

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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