Prediction of Risk of Vascular Structural Damage in Patients With Large Vessel Vasculitis (LVV) Based on PET/MRA Image Evaluation System

Nanjing Medical University150 enrolled

Overview

Large vessel vasculitis (LVV) causes vascular inflammation, leading to serious complications such as aneurysm formation and stroke. It is difficult to identify the inflammation of the vessel wall by the current imaging methods, thus affecting the timing of treatment and selection of treatment options. Improved examination methods to determine disease activity are highly needed to guide treatment.

This study was designed to assess vascular wall inflammation in patients with large vessel vasculitis by positron emission tomography and magnetic resonance imaging (PET/MRA). The study has a 12-month follow-up period. After completing the baseline clinical assessment, laboratory test and PET/MRA assessment, the intervention protocol will be determined by clinicians. The patients will visit the clinic every 1-2 months according to their specific conditions. Clinical assessment, laboratory test and PET/MRA re-examination will be completed at 6 and 12 months after treatment.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Large Vessel Vasculitis

Interventions

glucocorticoid, immunosuppressants, targeted therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Clinically suspected or confirmed LVV and willing to undergo PET/MRA 2. Compliance with long-term follow-up 3. Sign informed consent. Exclusion Criteria: 1. Patients with other serious cardiovascular and cerebrovascular diseases, malignant tumors, infectious diseases, severe renal insufficiency. 2. Severe mental disorders, severe claustrophobia unable to cooperate with the examination. 3. Patients equipped with cardiac pacemaker, artificial heart valve, ferromagnetic vascular clamp after vascular surgery, aneurysm clamp, artificial cochlea, insulin pump and other drug dosage control devices, steel nail plate and other metal internal fixation, artificial joint, electronic eye, artificial eye. 4. Allergic to contrast medium. 5. Pregnant or lactating women. Withdrawal criteria: 1. Any exclusion criteria emerged during patient follow-up. 2. Voluntarily withdrew from the study.

Outcomes

Primary Outcomes

Vascular structural progression

Vascular structural progression indicated by PET/MRA (including new vessel wall thickening, increased thickening, vascular stenosis or occlusion, aneurysm formation)

Time frame: 12 months

Secondary Outcomes

SUV max

Standardized uptake values（SUV） is a semiquantitative measurement of tumor uptake of FDG derived by measuring the ratio of radioactivity in the tumor to the expected baseline activity in the body. The SUVmax is defined as the maximum value for SUV in a Volume of interest (VOI) representing the highest metabolism in the tumor.

Time frame: 12 months

TBA

A template-based approach (TBA) consists in matching a model to the patient's anatomy so that the known attenuation map from the model can be applied to the patient data.

Time frame: 12 months

Prediction of Risk of Vascular Structural Damage in Patients With Large Vessel Vasculitis (LVV) Based on PET/MRA Image Evaluation System

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts