UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028647 |
|---|---|
| Receipt number | 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 | 2021/06/20 11:30:54 |
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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 | 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
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
takehiro.nakahara@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032785
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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