UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035956 |
|---|---|
| Receipt number | R000040951 |
| Scientific Title | Utility of [11C]4DST PET in assessing malignancy of tumors |
| Date of disclosure of the study information | 2019/02/21 |
| Last modified on | 2019/02/20 15:00:59 |
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Basic information
Public title
Utility of [11C]4DST PET in assessing malignancy of tumors
Acronym
Utility of [11C]4DST PET in assessing malignancy of tumors
Scientific Title
Utility of [11C]4DST PET in assessing malignancy of tumors
Scientific Title:Acronym
Utility of [11C]4DST PET in assessing malignancy of tumors
Region
| Japan |
Condition
Condition
Brain tumor, head and neck cancer, lung cancer, liver cancer, biliary tract cancer, pancreas cancer, musculoskeletal tumor, prostate cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Pneumology | Oto-rhino-laryngology |
| Orthopedics | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical utility of [11C]4DST PET in characterization and grading of various tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[11C]4DST uptake in tumors (visual assessment, SUV quantification, uptake count)
Key secondary outcomes
1) histological malignancy
2) FDG uptake in tumors
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
| Medicine |
Interventions/Control_1
[11C]4DST PET/CT
FDG PET/CT
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
1) Patients who have malignant tumors or are suspected to have malignant tumors.
2) Patients who agree and write informed consent form
Key exclusion criteria
1) Patients who are assumed to be difficult to implement the PET/CT examination due to general condition etc.
2) Women who are pregnant
3) Other patients who are judged inappropriate by research researcher, etc.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Saginoya |
Organization
Southern TOHOKU Research Institute for Neuroscience
Southern TOHOKU Medical Clinic
Division name
PET center
Zip code
Address
7-161 Yatsuyamada, Koriyama, Fukushima
TEL
024-934-5432
toshiyuki.saginoya@mt.strins.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Eto |
Organization
Southern TOHOKU Research Institute for Neuroscience
Division name
Corporate head office
Zip code
Address
7-115 Yatsuyamada, Koriyama, Fukushima
TEL
024-934-5322
Homepage URL
yoshihiro.eto@mt.strins.or.jp
Sponsor or person
Institute
Southern TOHOKU Research Institute for Neuroscience
Institute
Department
Personal name
Funding Source
Organization
Southern TOHOKU Research Institute for Neuroscience
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 21 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 20 | Day |
Last modified on
| 2019 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040951
