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

Application Value of Novel PET Tracers Targeting CAF in ANCA-Associated Vasculitis

This project will test whether Gallium-68 FAPI PET/CT scans can detect lung and kidney involvement in adults with ANCA-associated vasculitis.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07151521 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) who meet the 2022 ACR/EULAR criteria for ANCA-associated vasculitis and have HRCT-confirmed interstitial lung disease within the prior year and can provide informed consent.

Not a fit: Patients without ILD, those with other causes of lung or kidney disease, or with severe comorbidities or contraindications to PET/CT are unlikely to benefit from this imaging protocol.

Why it matters

Potential benefit: If successful, this imaging approach could enable earlier and more accurate detection of lung and kidney involvement, helping doctors tailor treatment and monitor disease course.

How similar studies have performed: FAPI PET has shown promise for imaging fibrotic and inflammatory activity in other conditions, but its application specifically to ANCA-associated vasculitis is novel with limited prior data.

Eligibility criteria

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 this trial is running

Shanghai

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

Study contacts

• Study coordinator: Hong-Lei Liu

Conditions ANCA-associated Vasculitis; ANCA-associated vasculitis; FAPI; PET/CT; ILD; Kidney