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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005278
Receipt No. R000006273
Scientific Title Comparison of findings among thyroid scintigraphy, FDG PET/CT and FLT PET/CT in thyroid cancer
Date of disclosure of the study information 2011/03/18
Last modified on 2018/03/23

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Basic information
Public title Comparison of findings among thyroid scintigraphy, FDG PET/CT and FLT PET/CT in thyroid cancer
Acronym Comparison of findings among thyroid scintigraphy, FDG PET/CT and FLT PET/CT in thyroid cancer
Scientific Title Comparison of findings among thyroid scintigraphy, FDG PET/CT and FLT PET/CT in thyroid cancer
Scientific Title:Acronym Comparison of findings among thyroid scintigraphy, FDG PET/CT and FLT PET/CT in thyroid cancer
Region
Japan

Condition
Condition Thyroid cncer
Classification by specialty
Endocrinology and Metabolism Endocrine surgery Oto-rhino-laryngology
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of FLT PET/CT by comparison with thyroid scintigraphy (I-123 or I-131 scintigraphy), FDG PET/CT in the same thyroid cancers
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Thyroid scintigraphy (I-123 or I-131 scintigraphy), FLT and FDG-PET/CT images are visually evaluated 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 3
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Scans start one day after oral administration of I-123 or three days after oral administration of I-131.
Interventions/Control_2 FDG PET/CT image acquisition start 1 hour after intravenous administration of FDG.
Interventions/Control_3 FLT PET/CT image acquisition start 1 hour after intravenous administration of FLT.
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 thyroid cancer who are evaluated about staging before and after therapy.
Key exclusion criteria None
Target sample size 60

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 Nanpuh hospital
Division name Radiology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Radiology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kagoshima University Hospital. Department of Radiology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Radiology, Nanpuh hospital
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 18 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
2010 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 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
2011 Year 03 Month 18 Day
Last modified on
2018 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006273

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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