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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06824714
Enrollment
150
Registered
2025-02-13
Start date
2024-01-01
Completion date
2028-07-01
Last updated
2025-02-13

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

Conditions

Large Vessel Vasculitis

Keywords

Large Vessel Vasculitis, PET, MRA, SUVmax, TBA

Brief summary

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.

Detailed description

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.

Interventions

DRUGglucocorticoid, immunosuppressants, targeted therapy

Drug intervention protocol will be determined by clinicians

Sponsors

Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Vascular structural progression12 monthsVascular structural progression indicated by PET/MRA (including new vessel wall thickening, increased thickening, vascular stenosis or occlusion, aneurysm formation)

Secondary

MeasureTime frameDescription
SUV max12 monthsStandardized 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.
TBA12 monthsA 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.

Countries

China

Contacts

Primary ContactRui LIU, MD
liurui_nanjing@163.com+86 15951871668
Backup ContactQian ZHANG, MD
zhq19921012@163.com+86 17702501489

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026