臨床研究等提出・公開システム

Date of registration	Mar. 18, 2019
Last modified on	Nov. 13, 2024
Trial ID	jRCTs031180361

Scientific Title	A pilot study of prognostic significance of arterial 18F-NaF and 18F-FDG uptake in patients with aortic aneurysm
Public Title	none (none)

Contact for Scientific Queries	Name	Jinzaki Masahiro
	Affiliation	Keio University School of Medicine
	Address	Shinanomati 35, Shinjuku-ku, Tokyo
	Telephone	+81-3-5363-3837
	E-mail	jinzaki@rad.med.keio.ac.jp
Contact for Public Queries	Name	NAKAHARA TAKEHIRO
	Affiliation	Keio University School of Medicine
	Address	Shinanomati 35, Shinjuku-ku, Tokyo
	Telephone	+81-3-5363-3837
	E-mail	takehiro.nakahara@keio.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 06, 2019
Actual date of first enrollment		July. 05, 2018
Target sample size		150
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	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.
	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
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		aortic aneurysm
Intervention(s)		18F-NaF PET and 18F-FDG PET studies and utilization of the images
Health Condition(s) Keyword		aortic aneurysm
Primary Outcome(s)		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.

Source of Monetary Support	Bayer Yakuhin, Ltd.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Certified Review Board of Keio
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Tokyo
Telephone	+81-3-5363-3503
E-Mail	med-rinri-jimu@adst.keio.ac.jp
Approval Status	Approval
Date of approval	Feb. 28, 2019

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	Nov. 13, 2024	(this page)	Changes
5	Nov. 01, 2021	Detail	Changes
4	Sept. 09, 2021	Detail	Changes
3	Feb. 08, 2021	Detail	Changes
2	Dec. 01, 2020	Detail	Changes
1	Mar. 18, 2019	Detail

List of change history