UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018639 |
|---|---|
| Receipt number | 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 12:59:31 |
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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
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
m-matsuda@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 Advanced Imaging Center
ImaginAb, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021571
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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