UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023101 |
|---|---|
| Receipt number | R000026420 |
| Scientific Title | [F-18]FDG and [C-11]Acetate PET/CT study for refractory diseases |
| Date of disclosure of the study information | 2016/07/15 |
| Last modified on | 2020/07/14 10:58:24 |
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Basic information
Public title
[F-18]FDG and [C-11]Acetate PET/CT study for refractory diseases
Acronym
[C-11]Acetate PET/CT study
Scientific Title
[F-18]FDG and [C-11]Acetate PET/CT study for refractory diseases
Scientific Title:Acronym
[C-11]Acetate PET/CT study
Region
| Japan |
Condition
Condition
hematologic malignancies and refractory or recurrent malignancies
Classification by specialty
| Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess accuray to determine disease status by [C-11]acetate PET/CT compared with [FDG]PET/CT in refractory hematologic malignanacies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy to detect lesions
Key secondary outcomes
Inter- and intra-observer variability
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
After intravenous administration of 3.7MBq/kg C-11 acetate, whole-body PET/CT is performed immediately. Subsequently, whole-body PET/CT is also performed 60 min after injection of 3.7MBq/kg F-18 FDG.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
i. [F-18]FDG PET/CT applicable for covered health insurance
ii. greater than or equal to 20 years old
iii. notification for malignant diseases
iv. obtained informed consent by document
Key exclusion criteria
i. serum glucose level greater than 200mg/dl
ii. pregnancy or possible
iii. patients can't demonstrate informed consent
iv. early gastric cancer in which [F-18]FDG PET/CT isn't applicable for covered health insurance
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ukihide |
| Middle name | |
| Last name | Tateishi |
Organization
Tokyo Medical and Dental University
Division name
Diagnostic Radiology
Zip code
1138519
Address
1-5-45, Yushima
TEL
03-5803-5311
ttisdrnm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Ukihide |
| Middle name | |
| Last name | Tateishi |
Organization
Tokyo Medical and Dental University
Division name
Diagnostic Radiology
Zip code
1138519
Address
1-5-45, Yushima
TEL
03-5803-5311
Homepage URL
ttisdrnm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Canon Medical Systems
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45, Yushima
Tel
03-5803-5311
radiologu.mrad@tmd.ac.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 15 | 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
40
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 | 07 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 11 | Day |
Last modified on
| 2020 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026420
