UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022799 |
|---|---|
| Receipt number | R000026276 |
| Scientific Title | The study to compare the hypoxic imaging of 18F-FAZA-PET/CT with the glucose metabolic imaging of 18F-FDG-PET/CT in patients with tumor |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2019/07/11 15:23:59 |
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Basic information
Public title
The study to compare the hypoxic imaging of 18F-FAZA-PET/CT with the glucose metabolic imaging of 18F-FDG-PET/CT in patients with tumor
Acronym
The comparison study between 18F-FAZA-PET/CT and 18F-FDG-PET/CT
Scientific Title
The study to compare the hypoxic imaging of 18F-FAZA-PET/CT with the glucose metabolic imaging of 18F-FDG-PET/CT in patients with tumor
Scientific Title:Acronym
The comparison study between 18F-FAZA-PET/CT and 18F-FDG-PET/CT
Region
| Japan |
Condition
Condition
Malignant tumors
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the diagnostic, therapeutic and prognostic values of 18F-FAZA-PET/CT for patients with malignant tumor by comparing with 18F-FDG-PET/CT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We compare the18F-FAZA-PET/CT findings with 18F-FDG-PET/CT findings before and after therapy in patients with malignant tumor.
Key secondary outcomes
Assessment of changes of the visual findings of both PET/CT examinations before and after therapy
Assessment of changes of the quantitative parameters (SUV, MTV and TLG) of both PET/CT examinations before and after therapy
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
The 18F-FAZA-PET/CT examination is performed in patient with malignant tumor before and after therapy
Interventions/Control_2
The 18F-FDG-PET/CT examination is performed in patient with malignant tumor before and after therapy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with malignant tumor who will be performed treatment
Key exclusion criteria
Patients with malignant tumor who will not be performed treatment
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Masatoyo |
| Middle name | |
| Last name | Nakajo |
Organization
Nanpuh Hospital
Division name
Radiology
Zip code
892-8512
Address
14-3 Nagata, Kagoshima, Japan
TEL
099-226-9111
toyo.nakajo@dolphin.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Yoriko |
| Middle name | |
| Last name | Kajiya |
Organization
Nanpuh Hospital
Division name
Radiology
Zip code
892-8512
Address
14-3 Nagata, Kagoshima, Japan
TEL
099-226-9111
Homepage URL
toyo.nakajo@dolphin.ocn.ne.jp
Sponsor or person
Institute
Nanpuh Hospital
Institute
Department
Personal name
Funding Source
Organization
Nanpuh Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nanpuh Hospital
Address
14-3 Nagata, Kagoshima, Japan
Tel
099-226-9111
crc-kenkyu@nanpuh.or.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
南風病院(鹿児島県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 01 | 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
22
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 | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 20 | Day |
Last modified on
| 2019 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026276
