Large Vessel VasculitisNCT06824714
Prediction of Risk of Vascular Structural Damage in Patients With Large Vessel Vasculitis (LVV) Based on PET/MRA Image Evaluation System
An observational study of Large Vessel Vasculitis, run by Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Vessel Vasculitis
- What is being tested?
- glucocorticoid, immunosuppressants, targeted therapy
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jul 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinically suspected or confirmed LVV
Who may be able to join
- Clinically suspected or confirmed LVV and willing to undergo PET/MRA
- Compliance with long-term follow-up
- Sign informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Rheumatology and Immunology, Jiangsu Province Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210029
Rui LIU, MD, +86 15951871668, liurui_nanjing@163.com
Qian ZHANG, MD, +86 17702501489, zhq19921012@163.com
About this study
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
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.
- Conditions
- Large Vessel Vasculitis
- Being tested
- glucocorticoid, immunosuppressants, targeted therapy
- Keywords
- Large Vessel Vasculitis, PET, MRA, SUVmax, TBA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucocorticoid, immunosuppressants, targeted therapyDrug
Drug intervention protocol will be determined by clinicians
| Study group | Role | What they receive |
|---|---|---|
| Clinically suspected or confirmed large vessel vasculitis (LVV) | Not described Receives: Drug: glucocorticoid, immunosuppressants, targeted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular structural progression
Vascular structural progression indicated by PET/MRA (including new vessel wall thickening, increased thickening, vascular stenosis or occlusion, aneurysm formation)
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Jan 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Large Vessel VasculitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui LIU, MD, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824714
- Sponsor's protocol ID
- 2024-SR-693
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 22925653Kostakoglu 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