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RecruitingNCT06824714Updated Feb 13, 2025

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

An observational study in Large Vessel Vasculitis, sponsored by Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.

Sponsored by Nanjing Medical University · Observational

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Large Vessel Vasculitis

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Keywords

  • Large Vessel Vasculitis
  • PET
  • MRA
  • SUVmax
  • TBA
03

In context

Vasculitis

170 studies on the registry are indexed under Vasculitis; 46 are open to participants now.

This study's planned enrollment of 150 is close to the median of 147 across 77 observational studies indexed under Vasculitis.

Browse Vasculitis studies →

Lead sponsor

Nanjing Medical University is the lead sponsor of 171 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Clinically suspected or confirmed LVV

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Clinically suspected or confirmed LVV and willing to undergo PET/MRA
  2. Compliance with long-term follow-up
  3. Sign .

Exclusion criteria

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 exclusion criteria emerged during patient follow-up.
  2. Voluntarily withdrew from the study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Clinically suspected or confirmed large vessel vasculitis (LVV)

    Drug: glucocorticoid, immunosuppressants, targeted therapy

Interventions

06

What researchers measure

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)

    Time frame: 12 months

Secondary outcomes

  1. SUV max

    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.

    Time frame: 12 months

  2. TBA

    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.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Department of Rheumatology and Immunology, Jiangsu Province Hospital, Nanjing Medical University
    Nanjing, Jiangsu 210029, China
    Recruiting
08

References and documents

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. PubMed 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. PubMed 29195618 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2024 (actual). Primary completion is estimated for Jan 2028, 48 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2025
First posted
Feb 13, 2025
StartActual
Jan 1, 2024
Primary completionEst.
Jan 1, 2028
CompletionEst.
Jul 1, 2028
Last update
Feb 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06824714
Responsible party
Rui LIU, MD (MD, Nanjing Medical University) — Principal investigator
First posted
Feb 13, 2025
Start date
Jan 1, 2024
Primary completion
Jan 1, 2028 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
Feb 13, 2025

Study contacts

Rui LIU, MD
Contact
liurui_nanjing@163.com
+86 15951871668
Qian ZHANG, MD
Contact
zhq19921012@163.com
+86 17702501489

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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