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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000040921

Enrollment

Registered

2020-06-28

Start date

2020-06-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid artery stenosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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)	—

Countries

Japan

Contacts

Public ContactToshiya Osanai

Hokkaido University Department of Neurosurgery, Faculty of medicine

osanait@med.hokudai.ac.jp0117065987

Outcome results