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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005026
Receipt No. R000005980
Scientific Title Comparison of findings between FDG PET/CT and FLT PET/CT in malignant tumor
Date of disclosure of the study information 2011/02/04
Last modified on 2011/02/16

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Basic information
Public title Comparison of findings between FDG PET/CT and FLT PET/CT in malignant tumor
Acronym Comparison of findings between FDG PET/CT and FLT PET/CT in malignant tumor
Scientific Title Comparison of findings between FDG PET/CT and FLT PET/CT in malignant tumor
Scientific Title:Acronym Comparison of findings between FDG PET/CT and FLT PET/CT in malignant tumor
Region
Japan

Condition
Condition Digestive cancer (esophagus cancer, stomach cancer, large intestine cancer, and pancreatic carcinoma)
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Endocrinology and Metabolism Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Endocrine surgery Breast surgery Pediatrics
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of 18F FLT PET/CT by comparison with 18F FDG PET/CT in the same malignant tumors
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Both FLT and FDG-PET/CT images were evaluated visually and semiquantitatively by calculating the maximum standardized uptake value (SUVmax).
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 FDG PET/CT image acquisition started 1 hour after intravenous administration of FDG, and after 3-7days FLT PET/CT image acquisition started 1 hour after intravenous administration of FLT
Interventions/Control_2 FLT PET/CT image acquisition started 1 hour after intravenous administration of FLT, and after 3-7days FDG PET/CT image acquisition started 1 hour after intravenous administration of FDG.
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 The patients with malignant tumor who are evaluated about staging before and after therapy.
Key exclusion criteria None
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoyo Nakajo1, Yoriko Kajiya2
Organization 1 Kagoshima University, Graduate School of Medical and Dental Sciences
2 Nanpu hospital
Division name Radiology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan
TEL 099-275-5417
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masatoyo Nakajo1, Yoriko Kajiya2
Organization Nanpu hospital
Division name Radiology
Zip code
Address 14-3 Nagata, Kagoshima 892-8512, Japan
TEL 099-226-9111
Homepage URL
Email y.kajiya@nanpuh.or.jp

Sponsor
Institute Nanpuh hospital
Institute
Department

Funding Source
Organization Nanpuh hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization None

Other related organizations
Co-sponsor Department of Radiology, Kagoshima University, Graduate School of Medical and Dental Sciences
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 南風病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 04 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 Enrolling by invitation
Date of protocol fixation
2010 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 02 Month 04 Day
Last modified on
2011 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005980

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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