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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016359
Receipt No. R000018997
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 2015/01/30
Last modified on 2017/07/31

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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
Cardiology Neurology 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.
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 Explanatory
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria at the time of written informed consent are eligible for study entry.
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 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 of more than 1000 ng/mL
10)History of allergy to iron preparations
11)Current use of other iron preparations
12)Current treatment for or past history of liver disease
13)Renal failure
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
Email 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
Email yitaya@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 30 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 12 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 30 Day
Last follow-up date
2015 Year 09 Month 30 Day
Date of closure to data entry
2015 Year 09 Month 30 Day
Date trial data considered complete
2015 Year 09 Month 30 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information Participants will be followed up to 7 days after the administration of Fermoxytol to assess adverse effects.

Management information
Registered date
2015 Year 01 Month 28 Day
Last modified on
2017 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018997

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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