UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000007575
Receipt No. 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 (Ver. 11)

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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
Last 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
Email pet-ml@shigamed.jp

Public contact
1st 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/
Email pet-ml@shigamed.jp

Sponsor
Institute Shiga Medical Center Research Institute
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008935