UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017509 |
|---|---|
| Receipt number | R000018890 |
| Scientific Title | Exploratory study for feasibility of MR macrophage imaging with Fermoxytol in patients with unruptured cerebral aneurysms |
| Date of disclosure of the study information | 2015/05/12 |
| Last modified on | 2017/05/14 17:48:56 |
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Basic information
Public title
Exploratory study for feasibility of MR macrophage imaging with Fermoxytol in patients with unruptured cerebral aneurysms
Acronym
MR macrophage imaging study for unruptured cerebral aneurysms
Scientific Title
Exploratory study for feasibility of MR macrophage imaging with Fermoxytol in patients with unruptured cerebral aneurysms
Scientific Title:Acronym
MR macrophage imaging study for unruptured cerebral aneurysms
Region
| Japan |
Condition
Condition
Unruptured cerebral aneurysms
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Macrophages that accumulate in lesion areas will be visualized on MR images using superparamagnetic iron oxide as a contrast agent in patients with unruptured cerebral aneurysms. The imaging findings will be analyzed to evaluate positive rates by aneurysm size and quantifiability of brightness on the images obtained with macrophage imaging and to assess the feasibility of macrophage imaging using a superparamagnetic iron oxide.
The safety of ferumoxytol, a contrast agent, for 7 days following administration will also be evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
Positive or negative assessment by aneurysm size based on macrophage imaging using MR T2* imaging
Key secondary outcomes
Quantification of brightness on the images obtained with macrophage imaging
Adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) An unruptured saccular cerebral aneurysm 3 mm or larger detected by MRA or 3D-CT angiography
(including aneurysms 25 mm or larger and partially thrombosed aneurysms)
2) Age of 20 years or older and below 65 years at the time of informed consent
3) Written informed consent to participate in this study obtained from the patients themselves
Key exclusion criteria
1) History of ruptured cerebral aneurysm
2) Multiple cerebral aneurysms (patients may be enrolled if the size of the concomitant aneurysm is smaller than 3 mm)
3) History of surgical treatment for cerebral aneurysm or intracranial disease
4) Past or current history of intracranial disease (intracerebral hemorrhage, cerebral infarction, brain tumor, head trauma)
5) Cerebral aneurysm developed secondary to vasculitis, vascular malformation, or other diseases
6) Special cerebral aneurysm called completely thrombosed giant aneurysm or giant fusiform aneurysm
7) Patients assessed to need immediate surgical treatment at the time of detection of unruptured cerebral aneurysm
8) Current use of anti-inflammatory drugs (e.g., NSAIDs, COX-2 inhibitors, steroids, statins)
9) Serum ferritin level equal or more than 1000 ng/mL
10) History of allergy to drugs including iron preparations
11) Current use of other iron preparations
12) Current treatment for or past history of liver disease
13) Renal failure or multiple comorbidities
14) Hypotension with systolic blood pressure < 100 mmHg or treatment of hypotension
15) Pregnancy or childbearing potential
16) Lactation
17) Inability to undergo MRI due to the presence of a pacemaker, claustrophobia, or other reason
18) Difficulty in acquisition of MR images of the cerebral aneurysm due to artifacts or other reason
19) Patients assessed by the investigator to be ineligible for the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nozaki |
Organization
Shiga University of Medical Science
Division name
Department of Neurosurgery
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2257
noz@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Itaya |
Organization
Shiga University of Medical Science Hospital
Division name
Clinical research center
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2953
Homepage URL
yitaya@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
滋賀医科大学（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 30 | Day |
Other
Other related information
Macrophages that accumulate in lesion areas will be visualized on MR images using superparamagnetic iron oxide as a contrast agent in patients with unruptured cerebral aneurysms. The imaging findings will be analyzed to evaluate positive rates by aneurysm size and quantifiability of brightness on the images obtained with macrophage imaging and to assess the feasibility of macrophage imaging using a superparamagnetic iron oxide.
The safety of ferumoxytol, a contrast agent, for 7 days following administration will also be evaluated.
Management information
Registered date
| 2015 | Year | 05 | Month | 11 | Day |
Last modified on
| 2017 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018890
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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