UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007575 |
|---|---|
| Receipt number | R000008935 |
| Scientific Title | Positron emission tomography using a newly-developed PET probe: [18F] Fluoroacetate (FACE) - human volunteer study - |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2019/03/27 11:54:51 |
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Basic information
Public title
Positron emission tomography using a newly-developed PET probe: [18F] Fluoroacetate (FACE) - human volunteer study -
Acronym
FACE volunteer study
Scientific Title
Positron emission tomography using a newly-developed PET probe: [18F] Fluoroacetate (FACE) - human volunteer study -
Scientific Title:Acronym
FACE volunteer study
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With the use of new PET tracer, [18F] Fluoroacetate (FACE), we would like to establish a new molecular imaging PET study for the quantitative evaluation of TCA cycle/ membrane metabolism of cancers, heart diseases, and brain. This study is the first trial with healthy volunteers.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Dynamic data acquisition (0 min after the intravenous injection up to 3hr after injection) using PET machine.
Key secondary outcomes
Radiation exposure will be also evaluated using dynamic data.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Injection dose 5.0MBq per kg, maximum dose 370MBq.
Dynamic and static data acquisition up to 1.5 hours.
Venous blood sampling up to 32mL.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy volunteer
Key exclusion criteria
a person with a disease (diseases)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Higashi |
Organization
Shiga Medical Center Research Institute
Division name
Division of Imaging Research
Zip code
Address
5-4-40 Moriyama, Moriyama-City, Shiga
TEL
077-582-6034
pet-ml@shigamed.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Higashi |
Organization
Shiga Medical Center Research Institute
Division name
Division of Imaging Research
Zip code
Address
5-4-40 Moriyama, Moriyama-City, Shiga
TEL
077-582-6034
Homepage URL
http://www.shigamed.jp/
pet-ml@shigamed.jp
Sponsor or person
Institute
Shiga Medical Center Research Institute
Institute
Department
Personal name
Funding Source
Organization
Shiga Medical Center Research Institute
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
滋賀県立総合病院研究所
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.shigamed.jp/
Publication of results
Published
Result
URL related to results and publications
http://www.shigamed.jp/
Number of participants that the trial has enrolled
4
Results
Annals of Nuclear Medicine
Ann Nucl Med (2014) 28:371-380
Assessment of [18F]-fluoroacetate PET/CT as a tumor-imaging
modality: preclinical study in healthy volunteers and clinical
evaluation in patients with liver tumor
Results date posted
| 2019 | Year | 03 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2014 | Year | 03 | Month | 06 | Day |
Baseline Characteristics
Twenty four normal healthy volunteers
(male: 15, female: 9)
Participant flow
Recruit for volunteers was performed by web homepage of our institute. After the obtain of informed consent, volunteers participate our study.
Adverse events
none
Outcome measures
We performed whole-body static
PET/CT scan using 18F-FACE (n = 34) and 18F-FDG (n = 5 for volunteers, n = 8 for patients) on each day,
respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Ann Nucl Med. 2014 May;28(4):371-80. doi: 10.1007/s12149-014-0823-z. Epub 2014 Mar 6.
Management information
Registered date
| 2012 | Year | 03 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008935
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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