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Recruiting NCT06824714

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

— Observational Large Vessel Vasculitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: glucocorticoid, immunosuppressants, targeted therapy.
Who it may be relevant to
Registry conditions: Large Vessel Vasculitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

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.

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

  • Drug glucocorticoid, immunosuppressants, targeted therapy
    Drug intervention protocol will be determined by clinicians

Primary outcome measures

  • Vascular structural progression [Time frame: 12 months]
Secondary outcome measures (2)
  • SUV max [Time frame: 12 months]
  • TBA [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Rheumatology and Immunology, Jiangsu Province Hospital, Nanjing Medical Univ — Nanjing

Publications

  • Martinez-Moller A, Nekolla SG. Attenuation correction for PET/MR: problems, novel approaches and practical solutions. Z Med Phys. 2012 Dec;22(4):299-310. doi: 10.1016/j.zemedi.2012.08.003. Epub 2012 Aug 25. PMID 22925653
  • Kostakoglu L, Chauvie S. Metabolic Tumor Volume Metrics in Lymphoma. Semin Nucl Med. 2018 Jan;48(1):50-66. doi: 10.1053/j.semnuclmed.2017.09.005. PMID 29195618

Identifiers

NCT: NCT06824714 · 2024-SR-693

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗