Visualization of Carotid Plaque Inflammatory Lesions by 18F-FDG PET/CT and Comparison with Histopathological Findings

UMIN ID: UMIN000040921

Registered date:28/06/2020

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Carotid artery stenosis
• Date of first enrollment: 2020/06/29
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: 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.
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Hokkaido University
• Source(s) of Monetary Support: MEXT Japan