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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023101
Receipt No. 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

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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
Email 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
Email ttisdrnm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026420

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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