UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006156 |
|---|---|
| Receipt number | R000006797 |
| Scientific Title | Diagnosis of glaucoma with MRI and PET using [11C](R)-PK11195 |
| Date of disclosure of the study information | 2011/08/12 |
| Last modified on | 2011/11/10 13:03:27 |
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Basic information
Public title
Diagnosis of glaucoma with MRI and PET using [11C](R)-PK11195
Acronym
Glaucoma diagnosis with PK11195-PETand MRI
Scientific Title
Diagnosis of glaucoma with MRI and PET using [11C](R)-PK11195
Scientific Title:Acronym
Glaucoma diagnosis with PK11195-PETand MRI
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine accumulation of activated microglia labelled with [11C](R)-PK11195 at lateral geniculate body and study the usefulness of PET in a diagnosis of glaucoma. Where there is accumulation, we will study a relationship between an extent of the accumulation and other clinical findings such as perimetry, optic disc changes and optic nerve changes on MRI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The presence or absence, if present the extent of intensiy , of accumulation at lateral geniculate body on PET
Key secondary outcomes
Perimetric changes, optic nerve cupping, changes of the optic nerve on MRI
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
intravenous injection of [11C](R)-PK11195 (3MBq/kg body weight, 180MBq for 60 kg body weight)
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
patients with primary open angle glaucoma and healthy adults
Key exclusion criteria
High myopic eye ( more than -8.00 diopters), eyes with other diseases, eyes with highly advanced loss of visual fields, eyes with visual field loss due to other diseases, claustrophobic
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunihiko Shiraki |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Ophthalmology and Visual Sciences
Zip code
Address
1-4-3 Asahimachi Abenoku Osaka Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Ophthalmology and Visual Sciences
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology and Visual Sciences, Graduate School of Medicine, Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Department of Molecular Pharmacology, Gifu Pharmaceutical University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Physiology, Graduate School of Medicine, Osaka City University
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
大阪市立大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 12 | 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
Eight patients (male: 5, female: 3) were examined. Their age ranged from 44 to 76 y.o. and the glaucomatous visual field defects ranged from grade3a to 5a in Kozaki's classification. Accumulation of 3 MBq/Kg of 11C(R)-PK11195 was unremarkable at the lateral geniculate nucleus of all the patients during 60 minutes PET examination with 4 x 30 seconds, 9 x 60 seconds, 3 x 180 seconds, 8 x 300 seconds.
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
| 2011 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 12 | Day |
Last modified on
| 2011 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006797
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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