Gallium-68 FAPI PET/CT imaging for people with ANCA-associated vasculitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with ANCA-associated vasculitis and HRCT-confirmed interstitial lung disease will undergo whole-body 68Ga-FAPI PET/CT to visualize fibroblast activation in the lungs and potential renal involvement. Imaging will be compared with prior HRCT and clinical data, with images interpreted by radiologists blinded to clinical details. This observational protocol collects imaging and clinical information without administering investigational treatments, aiming to map disease distribution in a single examination. Findings will be used to explore correlations between FAPI uptake and organ dysfunction or prognosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age over 18 years;
2. Meeting the 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for ANCA-associated vasculitis;
3. Diagnosed with concomitant interstitial lung disease based on High-Resolution Computed Tomography (HRCT) images obtained within one year prior to enrollment, interpreted by two radiologists blinded to clinical information;
4. Complete clinical information available;
5. Signed and dated informed consent form;
6. Willingness to comply with the study procedures and cooperate throughout the entire study process.

Exclusion Criteria:

1. Presence of other rheumatic diseases;
2. Presence of other conditions that may cause interstitial lung disease or renal impairment, such as systemic lupus erythematosus, dermatomyositis, or rheumatoid arthritis;
3. History of, or planned, hematopoietic stem cell transplantation;
4. Presence of severe comorbidities deemed by the investigators to be unsuitable for participation in this clinical study, such as severe cardiopulmonary insufficiency, severe bone marrow suppression, or severe hepatic or renal insufficiency;
5. Acute abdominal emergencies such as intestinal perforation or complete intestinal obstruction;
6. Pregnant or potentially pregnant women, and lactating women;
7. Poor treatment compliance.

Where it's running

• Ruiiin Hospital Shanghai JiaoTong University School of Medicine
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Hong-Lei Liu
• Email: hong-lei-liu@163.com
• Phone: +8617721375702

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.