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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028647
Receipt No. R000032785
Scientific Title A pilot study of prognostic significance of arterial 18F-NaF and 18F-FDG uptake in patients with aortic aneurysm
Date of disclosure of the study information 2017/08/12
Last modified on 2019/02/14

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Basic information
Public title A pilot study of prognostic significance of arterial 18F-NaF and 18F-FDG uptake in patients with aortic aneurysm
Acronym prognostic significance of 18F-NaF and 18F-FDG uptake in aortic aneurysm
Scientific Title A pilot study of prognostic significance of arterial 18F-NaF and 18F-FDG uptake in patients with aortic aneurysm
Scientific Title:Acronym prognostic significance of 18F-NaF and 18F-FDG uptake in aortic aneurysm
Region
Japan

Condition
Condition aortic aneurysm
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the relationship between 18F-NaF and 18F-FDG PET results and the enlargement of aortic diameter 24 months after PET examinations in the patients with aortic aneurysm.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between the uptake of 18F-NaF and 18F-FDG and the enlargement rate of aortic diameter 24 months after PET examinations in the patients with aortic aneurysm.
Key secondary outcomes

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 1. over 20 years old
2. Patients with aortic aneurysm in which diameter is over 45 mm for thoracic aortic aneurysm or 40 mm for abdominal aortic aneurysm
3. Patients with aortic aneurysm which is judeged by ardiovascular surgens not to be necessary for surgery for at least 1 year at the time of informed consent.
4. Patient who agree to participate in this study.
Key exclusion criteria 1. Allergic to FDG and NaF solution
2. History of vasculitis, autoimmune disease, and collagen disease
3. History of Marfan syndrome
4. Hisotyr of chemotherapy and radiation therapy within 8 weeks
5. Definitly or potentially pregnant woman or lactating woman
6. Uncontrolable diabetes mellitus
7. Poor performance status
8. Difficulty in coming to hospital because of poor physical activity
9. History of pshychiatric disorders
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Jinzaki
Organization Keio University School of Medicine
Division name Department of Diagnostic Radiology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3837
Email jinzaki@rad.med.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadaki Nakahara
Organization Keio University School of Medicine
Division name Department of Diagnostic Radiology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3837
Homepage URL
Email nakahara@rad.med.keio.ac.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd
Organization
Division
Category of Funding Organization Profit organization
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
2017 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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2017 Year 08 Month 12 Day
Last modified on
2019 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032785

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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