UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040921 |
|---|---|
| Receipt number | R000046723 |
| Scientific Title | Visualization of Carotid Plaque Inflammatory Lesions by 18F-FDG PET/CT and Comparison with Histopathological Findings |
| Date of disclosure of the study information | 2020/06/28 |
| Last modified on | 2024/01/16 08:58:17 |
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Basic information
Public title
Visualization of Carotid Plaque Inflammatory Lesions by 18F-FDG PET/CT and Comparison with Histopathological Findings
Acronym
Carotid Plaque study
Scientific Title
Visualization of Carotid Plaque Inflammatory Lesions by 18F-FDG PET/CT and Comparison with Histopathological Findings
Scientific Title:Acronym
Carotid Plaque study
Region
| Japan |
Condition
Condition
Carotid artery stenosis
Classification by specialty
| Vascular surgery | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the diagnostic ability of the novel 18F-FDG PET/CT for inflammatory plaques by comparing with the characterization of histological plaques using 18F-FDG PET/CT and histopathological findings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is to compare FDG accumulation (TBR) with histopathological findings of carotid plaque lesions.
Histopathological findings are classified into the following 5 categories.
1. Large lipid core with no or minimal intraplaque hemorrhage (LC): lipid >25% and hemorrhage <=25%.
2. A large intraplaque hemorrhage with minimal lipid component (IPH): hemorrhage >25% and lipid <=25%.
3. A lipid core mixed with intraplaque hemorrhage (LC+IPH): lipid >25% and hemorrhage >25%.
4. Calcification (Calc): calcification >25%.
5. Fibrous tissue (FT): fibrous tissue >50% without LC, IPH, and LC+IPH.
Key secondary outcomes
1.Comparison TBR in this study with cervical TBR in non-coronary artery disease group examined in previous studies
2. Assess the correlation between cervical TBR and biomarkers.
3. Relationship between cervical TBR and prognosis.
4. Evaluate the degree of improvement of inflammatory plaque after standard treatment (18F-FDG PET/CT)
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.Patients who are over 20 years old at the time of obtaining consent
2.Patients who are planed Carotid endarterectomy, with transient cerebral ischemic attack within the past 6 months or mild or moderate stroke with stenotic lesions of 50% or more or asymptomatic carotid artery stenosis of 60% or more.
3.Patients who have received sufficient explanation for participation in this study, and who have fully understood and agreed to the document by their own free will.
Key exclusion criteria
1.Patients who may become pregnant
2.Patients who cannot obtain written consent
3.Diabetic patients receiving continuous subcutaneous insulin infusion therapy, or patients who are considered unable to fast for 6 hours.
4.Other persons who are deemed inappropriate by the research supervisor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshiya |
| Middle name | |
| Last name | Osanai |
Organization
Hokkaido University
Division name
Department of Neurosurgery, Faculty of medicine
Zip code
0608638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL
0117065987
osanait@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Toshiya |
| Middle name | |
| Last name | Osanai |
Organization
Hokkaido University
Division name
Department of Neurosurgery, Faculty of medicine
Zip code
0608638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL
0117065987
Homepage URL
osanait@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
MEXT Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University hospital
Address
Kta 14, Nishi 5, kitaku, Sapporo
Tel
81-11-706-7636
crjimu@huhp.hokudai.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
| 2020 | Year | 06 | Month | 28 | 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
1
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
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) The 18F-FDG PET/CT-based inflammatory activity evaluation test and histopathological evaluation will be performed at the Hokkaido University Hospital, and the others will be performed at each participating research institution (hospital).
(2) Biochemical examination, physical examination, and physiological function examination
(3) Blood collection for research 20cc Carried out at Hokkaido University Hospital.
(4) Evaluate medical history using questionnaire (questionnaire for carotid examination) and medical record information, family history, medical history, smoking history/period, symptoms, etc.
(5) Imaging test (only when performed clinically)
(6) Histopathological evaluation
(7) Treatment details
(8) Prognosis evaluation
Management information
Registered date
| 2020 | Year | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046723
