UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026279 |
|---|---|
| Receipt number | R000030179 |
| Scientific Title | Human Radiation Dosimetry for the Neurokinin-1 Receptor Radioligand 11C-GR205171 |
| Date of disclosure of the study information | 2017/03/07 |
| Last modified on | 2017/02/23 15:47:28 |
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Basic information
Public title
Human Radiation Dosimetry for the Neurokinin-1
Receptor Radioligand 11C-GR205171
Acronym
Human Radiation Dosimetry for the 11C-GR205171
Scientific Title
Human Radiation Dosimetry for the Neurokinin-1
Receptor Radioligand 11C-GR205171
Scientific Title:Acronym
Human Radiation Dosimetry for the 11C-GR205171
Region
| Japan |
Condition
Condition
Normal Volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe whole body distribution and measure radiation dosimetry of C-11 GR205171 in normal volunteers
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To measure radiation dosimetry of C-11 GR205171 in normal volunteers
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
C-11 GR205171 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
*Normal hepatic and renal function
*No history of hepatic virus infection
*No abdominal surgical history
Key exclusion criteria
*The healthy volunteer who can not keep face up position because of sharp pain in succession for a round 90 minutes.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shozo Hirota |
Organization
Hyogo College of Medicine
Division name
Radiology
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6362
hirota-s@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhito Fukushima |
Organization
Hyogo College of Medicine
Division name
Radiology
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6883
Homepage URL
fuku0106@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 03 | Month | 07 | 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
Date of protocol fixation
| 2017 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 09 | 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
| 2017 | Year | 02 | Month | 23 | Day |
Last modified on
| 2017 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030179
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
