UMIN-CTR Clinical Trial

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 Masahiro Middle name Last name Jinzaki
Organization	Keio University School of Medicine
Division name	Department of Diagnostic Radiology
Zip code	1608582
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 Takehiro Middle name Last name Nakahara
Organization	Keio University School of Medicine
Division name	Department of Diagnostic Radiology
Zip code	1608582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3837
Homepage URL
Email	takehiro.nakahara@keio.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	Certified Review Board of Keio
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
Tel	03-5363-3503
Email	med-nintei-jimu@adst.keio.ac.jp

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	2021 Year 06 Month 20 Day

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