Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06824714

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Rheumatology and Immunology, Jiangsu Province Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location status: Recruiting

Location contact

Qian ZHANG, MD

CONTACT

[email protected]

+86 17702501489

Qian ZHANG, MD

SUB_INVESTIGATOR

Rui LIU, MD

CONTACT

[email protected]

+86 15951871668

Rui LIU, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically suspected or confirmed LVV and willing to undergo PET/MRA
  • Compliance with long-term follow-up
  • Sign informed consent.

Exclusion criteria

  • Patients with other serious cardiovascular and cerebrovascular diseases, malignant tumors, infectious diseases, severe renal insufficiency.
  • Severe mental disorders, severe claustrophobia unable to cooperate with the examination.
  • 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.
  • Allergic to contrast medium.
  • Pregnant or lactating women.

Withdrawal criteria:

  • Any exclusion criteria emerged during patient follow-up.
  • Voluntarily withdrew from the study.

Treatment and study plan

glucocorticoid, immunosuppressants, targeted therapy

Drug

Drug intervention protocol will be determined by clinicians

Primary outcomes

  1. Vascular structural progression

    Time frame: 12 months

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

Secondary outcomes

  1. SUV max

    Time frame: 12 months

    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.

  2. TBA

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qian ZHANG, MD

CONTACT

[email protected]

+86 17702501489

Rui LIU, MD

CONTACT

[email protected]

+86 15951871668

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.