NCT06824714

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
26mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Jan 2024Jul 2028

Study Start

First participant enrolled

January 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

4 years

First QC Date

February 7, 2025

Last Update Submit

February 7, 2025

Conditions

Large Vessel Vasculitis

Keywords

Large Vessel VasculitisPETMRASUVmaxTBA

Outcome Measures

Primary Outcomes (1)

  • Vascular structural progression

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

    12 months

Secondary Outcomes (2)

  • SUV max

    12 months

  • TBA

    12 months

Study Arms (1)

Clinically suspected or confirmed large vessel vasculitis (LVV)

Drug: glucocorticoid, immunosuppressants, targeted therapy

Interventions

glucocorticoid, immunosuppressants, targeted therapyDRUG

Drug intervention protocol will be determined by clinicians

Clinically suspected or confirmed large vessel vasculitis (LVV)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Clinically suspected or confirmed LVV

You may qualify if:

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

You may not qualify if:

  • 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:
  • Voluntarily withdrew from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (2)

  • 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: 22925653BACKGROUND

  • 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: 29195618BACKGROUND

MeSH Terms

Interventions

GlucocorticoidsImmunosuppressive Agents

Intervention Hierarchy (Ancestors)

Adrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesImmunologic Factors

Central Study Contacts

Rui LIU, MD

CONTACT

+86 15951871668liurui_nanjing@163.com

Qian ZHANG, MD

CONTACT

+86 17702501489zhq19921012@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 13, 2025

Study Start

January 1, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

February 13, 2025

Record last verified: 2025-02

Locations

CN(1)