UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study for feasibility of MR macrophage imaging with Fermoxytol in patients with unruptured cerebral aneurysms
Title of the study (Brief title)	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	Kazuhiko Nozaki
Organization	Shiga University of Medical Science
Division name	Department of Neurosurgery
Address	Seta Tsukinowa-cho, Otsu, Shiga
TEL	077-548-2257
Email	noz@belle.shiga-med.ac.jp

Public contact
Name of contact person	Yukiko Itaya
Organization	Shiga University of Medical Science Hospital
Division name	Clinical research center
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	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018890