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

NCT ID: NCT06824714

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2028-07-01

Brief Summary

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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

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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.

Conditions

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Large Vessel Vasculitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Clinically suspected or confirmed large vessel vasculitis (LVV)

glucocorticoid, immunosuppressants, targeted therapy

Intervention Type DRUG

Drug intervention protocol will be determined by clinicians

Interventions

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glucocorticoid, immunosuppressants, targeted therapy

Drug intervention protocol will be determined by clinicians

Intervention Type DRUG

Eligibility Criteria

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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:

2. Voluntarily withdrew from the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Rui LIU, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rui LIU, MD

Role: CONTACT

+86 15951871668

Qian ZHANG, MD

Role: CONTACT

+86 17702501489

Facility Contacts

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Rui LIU, MD

Role: primary

+86 15951871668

Qian ZHANG, MD

Role: backup

+86 17702501489

References

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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.

Reference Type BACKGROUND
PMID: 22925653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29195618 (View on PubMed)

Other Identifiers

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2024-SR-693

Identifier Type: -

Identifier Source: org_study_id

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