Unique ID issued by UMIN | UMIN000015356 |
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Receipt number | R000017839 |
Scientific Title | A PET (positron emission tomography) clinical research study using prostate specific membrane antigen (PSMA) targeted tracer, 89Zr-Df-IAB2M |
Date of disclosure of the study information | 2014/10/08 |
Last modified on | 2016/10/07 18:02:25 |
A PET (positron emission tomography) clinical research study using prostate specific membrane antigen (PSMA) targeted tracer, 89Zr-Df-IAB2M
A PET (positron emission tomography) clinical research study using prostate specific membrane antigen (PSMA) targeted tracer, 89Zr-Df-IAB2M
A PET (positron emission tomography) clinical research study using prostate specific membrane antigen (PSMA) targeted tracer, 89Zr-Df-IAB2M
A PET (positron emission tomography) clinical research study using prostate specific membrane antigen (PSMA) targeted tracer, 89Zr-Df-IAB2M
Japan |
Prostate cancer / Urothelial carcinoma / Renal cell carcinoma / Testicular cancer
Urology | Radiology |
Malignancy
NO
Safety and pharmacokinetics research on 89Zr-Df-IAB2M in Japan as a new PET diagnostic tracer
Others
Safety, Efficacy/Pharmacokinetics
Exploratory
Phase I,II
Safety:
Subjective and Objective symptom, Vital data, Clinical tests, Radiation exposure,
Adverse events
1) Pharmacokinetics
2) Detection of cancer focus
3) PET imaging condition
4) Imaging of tumor neovascular
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Medicine |
Administration of unapproved drug
20 | years-old | <= |
Not applicable |
Male and Female
(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
(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
15
1st name | |
Middle name | |
Last name | Hiroyuki Nishiyama |
Faculty of Medicine, University of Tsukuba
Department of Urology
1-1-1 Tennodai, Tsukuba, Ibaraki
029-853-3223
nishiuro@md.tsukuba.ac.jp
1st name | |
Middle name | |
Last name | Akira Joraku |
Faculty of Medicine, University of Tsukuba
Department of Urology
1-1-1 Tennodai, Tsukuba, Ibaraki
029-853-3223
joruroa@md.tsukuba.ac.jp
University of Tsukuba
University of Tsukuba
Self funding
TSUKUBA Imaging Center
ImaginAb, Inc.
NO
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)
2014 | Year | 10 | Month | 08 | Day |
Unpublished
Completed
2014 | Year | 10 | Month | 01 | Day |
2014 | Year | 11 | Month | 01 | Day |
2016 | Year | 08 | Month | 31 | Day |
2016 | Year | 10 | Month | 31 | Day |
2016 | Year | 11 | Month | 30 | Day |
2017 | Year | 01 | Month | 31 | Day |
2014 | Year | 10 | Month | 06 | Day |
2016 | Year | 10 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017839
Research Plan | |
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