UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008837 |
|---|---|
| Receipt number | 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 10:52:07 |
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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 | Obstetrics 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
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/
kenkyu@res.med.shiga-pref.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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010381
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