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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023983
Receipt No. R000027601
Scientific Title Dynamic study of FDG-PET/CT
Date of disclosure of the study information 2016/09/30
Last modified on 2017/08/11

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Basic information
Public title Dynamic study of FDG-PET/CT
Acronym Dynamic study of FDG-PET/CT
Scientific Title Dynamic study of FDG-PET/CT
Scientific Title:Acronym Dynamic study of FDG-PET/CT
Region
Japan

Condition
Condition lung cancer, malignant lymphoma, uterine cancer, ovarian cancer, renal cancer
Classification by specialty
Medicine in general Pneumology Chest surgery
Obsterics and gynecology Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the early and delayed phases of FDG-PET/CT for the patient that malignant tumor is suspected. To evaluate the diagnostic ability in the detection of malignant lesions by addition of the early and delayed phases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To be able to predict the histology of lesions by dynamic uptake pattern in the lesions obtained by addition of early and delayed phase.
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 Addition of early and delayed phases to usual imaging.
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
4 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients that malignant tumor is suspected
Key exclusion criteria Patients with much body movement
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Harada
Organization Tokushima University Hospital
Division name Radiology
Zip code
Address 2-50-1, Kuramoto-cho, Tokushima
TEL 088-631-3111
Email otomi.yoichi@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoichi Otomi
Organization Tokushima University Hospital
Division name Radiology
Zip code
Address 2-50-1, Kuramoto-cho, Tokushima
TEL 088-631-3111
Homepage URL
Email otomi.yoichi@tokushima-u.ac.jp

Sponsor
Institute Tokushima University Hospital
Institute
Department

Funding Source
Organization Tokushima University Hospital
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
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
2016 Year 09 Month 30 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
2016 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 20 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
2016 Year 09 Month 08 Day
Last modified on
2017 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027601

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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