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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008837
Receipt No. R000010381
Scientific Title Positron emission tomography using a newly-developed PET probe: [18F] fluoroacetate (FACE) - clinical patient study -
Date of disclosure of the study information 2012/09/03
Last modified on 2019/09/09

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Basic information
Public title Positron emission tomography using a newly-developed PET probe: [18F] fluoroacetate (FACE) - clinical patient study -
Acronym FACE clinical patient study
Scientific Title Positron emission tomography using a newly-developed PET probe: [18F] fluoroacetate (FACE) - clinical patient study -
Scientific Title:Acronym FACE clinical patient study
Region
Japan

Condition
Condition patients with cancers or with neurological diseases
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Hematology and clinical oncology Neurology
Geriatrics Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Vascular surgery Chest surgery
Endocrine surgery Breast surgery Obsterics and gynecology
Pediatrics Ophthalmology Dermatology
Psychiatry Oto-rhino-laryngology Orthopedics
Urology Radiology Oral surgery
Neurosurgery Adult
Classification by malignancy Malignancy
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 TAC cycle/ membrane metabolism of cancers, neurological diseases. This is the first trial with patients with cancers or with neurological diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Dynamic dat acquisition (0 min after the intravenous injection up to 2hr after injection) using PET scanner. Or static data acquisition (20 min 1hr after injection).
Key secondary outcomes Data obtained at studies with cancer patients can be used as control for neurological studies. Data obtained at studies with neurological patients can be used as control for studies with cancers.

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 or static data acquisition up to 2hr. Venous blood sampling (10mL).
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
90 years-old >=
Gender Male and Female
Key inclusion criteria patients with cancers or with neurological diseases
Key exclusion criteria none
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Chio
Middle name
Last name Okuyama
Organization Shiga Medical Center Research Institute
Division name Division of Imaging Research
Zip code 524-8524
Address 5-4-40 Moriyama, Moriyama-City, Shiga
TEL 077-582-6034
Email okuyama@res.med.shiga-pref.jp

Public contact
Name of contact person
1st name Shigenori
Middle name
Last name Shimomura
Organization Shiga Medical Center Research Institute
Division name Division of Imaging Research
Zip code 524-8524
Address 5-4-40 Moriyama, Moriyama-City, Shiga
TEL 077-582-6034
Homepage URL http://www.shigamed.jp/
Email kenkyu@res.med.shiga-pref.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

Other related organizations
Co-sponsor Kyoto University, Graduate School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB in Shiga General Hospital
Address 5-4-30, Moriyama-cho, Moriyama. Shiga.524-8524, Japan
Tel 07755826034
Email kenkyu@res.med.shiga-pref.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 滋賀県立総合病院研究所

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 03 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 19
Results 1.FACE uptake in hepatic tumors was significantly lower than those of FDG. In qualitative analysis, FDG and FACE were both positive in 4 of the same tumors. No superiority of FACE was found.
2.Significant decreases of CBF and CMRO2 and increases of OEF and CBV were found in the hemisphere ipsilateral to the chronic ischemic lesion with ICA or MCA stenosis, and FACE uptake was greater than that in the contralateral hemisphere.
Results date posted
2019 Year 09 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2014 Year 05 Month 01 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 09 Month 03 Day
Date of IRB
2012 Year 09 Month 13 Day
Anticipated trial start date
2012 Year 09 Month 13 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 12 Month 31 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.


Stoke. 2015;46:2669-2672. doi: 10.1161/STROKEAHA.115.010080. Epub 2015 Jul 30.

Management information
Registered date
2012 Year 09 Month 03 Day
Last modified on
2019 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010381

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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