UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005026 |
|---|---|
| Receipt number | 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 15:31:02 |
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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
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
y.kajiya@nanpuh.or.jp
Sponsor or person
Institute
Nanpuh hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005980
