UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015356
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

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Basic information

Public title

A PET (positron emission tomography) clinical research study using prostate specific membrane antigen (PSMA) targeted tracer, 89Zr-Df-IAB2M

Acronym

A PET (positron emission tomography) clinical research study using prostate specific membrane antigen (PSMA) targeted tracer, 89Zr-Df-IAB2M

Scientific Title

A PET (positron emission tomography) clinical research study using prostate specific membrane antigen (PSMA) targeted tracer, 89Zr-Df-IAB2M

Scientific Title:Acronym

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

1st name
Middle name
Last name Hiroyuki Nishiyama

Organization

Faculty of Medicine, University of Tsukuba

Division name

Department of Urology

Zip code


Address

1-1-1 Tennodai, Tsukuba, Ibaraki

TEL

029-853-3223

Email

nishiuro@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akira Joraku

Organization

Faculty of Medicine, University of Tsukuba

Division name

Department of Urology

Zip code


Address

1-1-1 Tennodai, Tsukuba, Ibaraki

TEL

029-853-3223

Homepage URL


Email

joruroa@md.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



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)



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

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


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

2014 Year 10 Month 01 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017839


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name