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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018639
Receipt No. R000021571
Scientific Title A PET (positron emission tomography) study using 89Zr-Df-IAB2M for glioma
Date of disclosure of the study information 2015/09/01
Last modified on 2017/02/13

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Basic information
Public title A PET (positron emission tomography) study using 89Zr-Df-IAB2M for glioma
Acronym A PET (positron emission tomography) study using 89Zr-Df-IAB2M for glioma
Scientific Title A PET (positron emission tomography) study using 89Zr-Df-IAB2M for glioma
Scientific Title:Acronym A PET (positron emission tomography) study using 89Zr-Df-IAB2M for glioma
Region
Japan

Condition
Condition Glioma
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the safety and availability of 89Zr-Df-IAB2M PET in glioma patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Safety:
Adverse events within the 2 days after intervention
Key secondary outcomes 1) Imaging of tumor neovasculature
2) PET imaging condition

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, single dose, 74MBq/10mg
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 more
(3) Patients who have the following examination findings
AST or ALT is not 2.5 fold higher than the upper normal range
T-bil is not 1.5 fold higher than the upper normal range
Serum albmin is more than 3.8 g/dl
Serum creatinine is not 1.5 fold higher than the upper normal range
Creatinine clearance is more than 60 ml/min
Key exclusion criteria (1) Patients without operative indication
(2) Patients with severe cardiovascular, respiratory, renal, gastrointestinal, hematological, or neuropsychiatric disease
(3) Patients whose doctors determined as inadequate for the study
Target sample size 10

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 Masahide Matsuda
Organization Faculty of Medicine, University of Tsukuba
Division name Department of Neurosurgery
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-3220
Homepage URL
Email m-matsuda@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 Advanced 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 Advanced Imaging Center (Ibaraki)

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 01 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
2015 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 11 Day
Last modified on
2017 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021571

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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