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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022066
Receipt No. 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

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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
Email 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
Email tshiga@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025442

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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