UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022066 |
|---|---|
| Receipt number | R000025442 |
| Scientific Title | First-in-human study of [18F]DiFA |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2017/04/27 09:43:23 |
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Basic information
Public title
First-in-human study of [18F]DiFA
Acronym
First-in-human study of [18F]DiFA
Scientific Title
First-in-human study of [18F]DiFA
Scientific Title:Acronym
First-in-human study of [18F]DiFA
Region
| Japan |
Condition
Condition
Normal volunteers
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study were to evaluate radiation dosimetry, biodistribution, human safety after injection of a single dose of [18F]DiFA prepared at Hokkaido University Hospital in healthy subjects.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase I
Assessment
Primary outcomes
To clarify the presence or the absence, the type, the severity, and frequency of adverse effects and to assess the causal relationship.
Key secondary outcomes
Pharmacokinetics
Exposure dose
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
Dose:105-740MBq
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
Normal volunteers
(1)aged 20-60 years old at agreement acquisition.
(2)gave a written informed consent.
(3)are nonsmokers or the persons who are available for smoking cessation during this study
(4)are nondrinkers or the persons who are available for temperance during this study
Key exclusion criteria
(1) The person who is abnormal in laboratory study at screening.
White blood cell differentiation is excluded)
(2)a history of blood, heart, hepatic or renal disease.
(3)The person who had an acute disease symptom (nausea, vomiting, fever, diarrhea) within 3 days before screening test
(4)any medical treatment including vitamin drug and Kanpo-drug within 7 days before enrollment.
(5)a donation of plasma to a blood bank or clinical study within 7 days
before enrollment.
a donation of over 200 ml whole blood to a blood bank or clinical studywithin 28 days before enrollment. a donation of over 400 ml whole blood to a blood bank or clinical study within 84 days before enrollment.
a donation of over 800 ml whole blood to a blood bank or clinical study within 365 days before enrollment.
(6) a history of hypersensitivity for medical drugs.
(7)a participation in other clinical trials at present or other clinical trial within 6 months before enrollment.
(8) a history of drug abuse or alcoholism.
(9)The person of the severe claustrophobia.
(10) The person who has a history of the poor physical condition by the medical act including drawing blood, the injection
(11)and subjects were excluded if the investigators judged as misfit for this study.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tohru Shiga |
Organization
Hokkaido University, Graduate School of Medicine
Division name
Department of Nuclear Medicine
Zip code
Address
N15,W7,Kita-Ku, Sapporo
TEL
011-706-5152
tshiga@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tohru Shiga |
Organization
Hokkaido University, Graduate School of Medicine
Division name
Department of Nuclear Medicine
Zip code
Address
N15, W7, Kita-Ku, Sapporo
TEL
011-706-5152
Homepage URL
tshiga@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
| 2016 | Year | 05 | Month | 09 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 02 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 26 | Day |
Last modified on
| 2017 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025442
