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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002048
Receipt No. R000002265
Scientific Title Evaluation study of diagnostic efficacy in malignant tumors using 11C-methionine PET/CT
Date of disclosure of the study information 2009/06/06
Last modified on 2019/04/01

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Basic information
Public title Evaluation study of diagnostic efficacy in malignant tumors using 11C-methionine PET/CT
Acronym Diagnostic efficacy of 11C-methionine PET/CT for malignant tumors.
Scientific Title Evaluation study of diagnostic efficacy in malignant tumors using 11C-methionine PET/CT
Scientific Title:Acronym Diagnostic efficacy of 11C-methionine PET/CT for malignant tumors.
Region
Japan

Condition
Condition Malignant tumor
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Neurology Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate diagnostic efficacy of 11C- methionine PET/CT for malignant tumors of limited FDG PET efficacy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Concordance with histological diagnosis of surgical specimen. Concordance of clinical stage with postsurgical stage.
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
Medicine Maneuver
Interventions/Control_1 11C-methionine PET/CT
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 Patients who meet all of the following conditions.1. Malignant tumor of either brain, mediastinum, lung, or urinary tract2. Surgery is planned 3. Medically fits for surgery4. Written informed consent obtained.
Key exclusion criteria Patients who meet at least one of the following conditions.1. Malignant tumor of neiother brain, mediastinum, lung, nor urinary tract.2. Medically unfit for surgery or suegery not planned.3. Informed consent not given.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Ichiei
Middle name
Last name Kuji
Organization Saitama Medical University
Division name Saitama International Medical Center
Zip code 350-1298
Address Yamane 1397-1, Hidaka-shi, Saitama
TEL 042-984-4147
Email kuji@saitama-med.ac.jp

Public contact
Name of contact person
1st name Ichiei
Middle name
Last name Kuji
Organization Saitama Medical University International Medical Center
Division name Clinical Trial Support Center
Zip code 350-1298
Address Yamane 1397-1, Hidaka-shi, Saitama
TEL 042-984-4523
Homepage URL
Email chikens@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Radiology
Saitama Medical Center
Saitama Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saitama Medical University International Medical Center IRB
Address Yamane 1397-1, Hidaka-shi, Saitama
Tel 042-984-4523
Email chikens@saitama-med.ac.jp

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 埼玉医科大学国際医療センター
埼玉医科大学総合医療センター

Other administrative information
Date of disclosure of the study information
2009 Year 06 Month 06 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 1563
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 Terminated
Date of protocol fixation
2007 Year 07 Month 09 Day
Date of IRB
2007 Year 07 Month 18 Day
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 05 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002265

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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