UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	First-in-human study of [18F]DiFA
Title of the study (Brief title)	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	Tohru Shiga
Organization	Hokkaido University, Graduate School of Medicine
Division name	Department of Nuclear Medicine
Address	N15,W7,Kita-Ku, Sapporo
TEL	011-706-5152
Email	tshiga@med.hokudai.ac.jp

Public contact
Name of contact person	Tohru Shiga
Organization	Hokkaido University, Graduate School of Medicine
Division name	Department of Nuclear Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000025442