UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A PET (positron emission tomography) clinical research study using prostate specific membrane antigen (PSMA) targeted tracer, 89Zr-Df-IAB2M
Title of the study (Brief title)	A PET (positron emission tomography) clinical research study using prostate specific membrane antigen (PSMA) targeted tracer, 89Zr-Df-IAB2M
Region	Japan

Condition
Condition	Prostate cancer / Urothelial carcinoma / Renal cell carcinoma / Testicular cancer
Classification by specialty	Urology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety and pharmacokinetics research on 89Zr-Df-IAB2M in Japan as a new PET diagnostic tracer
Basic objectives2	Others
Basic objectives -Others	Safety, Efficacy/Pharmacokinetics
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Safety: Subjective and Objective symptom, Vital data, Clinical tests, Radiation exposure, Adverse events
Key secondary outcomes	1) Pharmacokinetics 2) Detection of cancer focus 3) PET imaging condition 4) Imaging of tumor neovascular

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	Administration of unapproved drug
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) Patient is over 20 years old at the time of informed consent. (2) Karnofsky Performance Status (KPS) is 70 or over (3) Patients who have the following clinical examination AST or ALT is 2.5 fold higher than normal range T-Bil is 1.5 fold higher than normal range Serum albumin is more than 2..0 g/dl Serum creatinine is1.5 fold or less than normal range Creatinine clearance is more than 60 mL/min
Key exclusion criteria	(1) In a clinical trial, patients who need to receive the new treatment (2) Patinets with severe pulmonary, renal, gastrointestinal, hematological or psychonurological disease (3) Patients whose doctors determined as inadequate for the study
Target sample size	15

Research contact person
Name of lead principal investigator	Hiroyuki Nishiyama
Organization	Faculty of Medicine, University of Tsukuba
Division name	Department of Urology
Address	1-1-1 Tennodai, Tsukuba, Ibaraki
TEL	029-853-3223
Email	nishiuro@md.tsukuba.ac.jp

Public contact
Name of contact person	Akira Joraku
Organization	Faculty of Medicine, University of Tsukuba
Division name	Department of Urology
Address	1-1-1 Tennodai, Tsukuba, Ibaraki
TEL	029-853-3223
Homepage URL
Email	joruroa@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	University of Tsukuba
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	TSUKUBA Imaging Center ImaginAb, Inc.
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	筑波大学附属病院（茨城県）University of Tsukuba Hospital(Ibaraki) つくば画像検査センター（茨城県）TSUKUBA Imaging Center(Ibaraki)

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 01 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date	2016 Year 08 Month 31 Day
Date of closure to data entry	2016 Year 10 Month 31 Day
Date trial data considered complete	2016 Year 11 Month 30 Day
Date analysis concluded	2017 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 06 Day
Last modified on	2016 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017839