(68)Ga-FAPI PET/CT in Patients With ANCA-associated Vasculitis

NCT07151521 | Recruiting

• 1 other identifier: 2025-432
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary and renal involvement are the most common clinical manifestations of antineutrophil cytoplasmic antibody(ANCA)-associated vasculitis (AAV). Studies have shown that both interstitial lung disease (ILD) and renal dysfunction are closely associated with poor prognosis in patients with AAV. Therefore, early identification of whether AAV patients have concomitant ILD and renal involvement is of great clinical importance for assessing disease severity, stratifying prognostic risk, and developing individualized treatment strategies. Positron emission tomography (PET) is a noninvasive molecular imaging technique that can provide decision-making support for early and accurate diagnosis, timely intervention, as well as evaluation of treatment response and prognosis. In the same individual, PET enables whole-body localization of disease in a single examination, overcoming the limitation of conventional diagnostic methods that typically assess only one region at a time, thereby facilitating patient benefit. In recent years, many novel PET tracers have been developed and introduced into clinical practice. 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) has been studied in the diagnosis of various malignant and nonmalignant diseases; it targets fibroblast activation protein (FAP) and thus reflects the distribution of cancer-associated fibroblasts (CAFs). However, its clinical significance in AAV remains to be further investigated. This study aims to use a CAF-targeted novel PET tracer to conveniently and noninvasively detect the real-time distribution of lesions in patients, providing valuable information for personalized diagnosis and treatment.

Conditions

ANCA-associated Vasculitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Disease severity and activity in ANCA-associated vasculitis with concomitant interstitial lung disease and renal dysfunction as measured by 68Ga-FAPI PET/CT.

  Within 4 weeks after enrollment

Study Arms (4)

ANCA-associated vasculitis with interstitial lung disease

ANCA-associated vasculitis without interstitial lung disease

ANCA-associated vasculitis with renal dysfunction

ANCA-associated vasculitis without renal dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants in this study will be recruited from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine.

You may qualify if:

• Age over 18 years;
• Meeting the 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for ANCA-associated vasculitis;
• 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;
• Complete clinical information available;
• Signed and dated informed consent form;
• Willingness to comply with the study procedures and cooperate throughout the entire study process.

You may not qualify if:

• Presence of other rheumatic diseases;
• Presence of other conditions that may cause interstitial lung disease or renal impairment, such as systemic lupus erythematosus, dermatomyositis, or rheumatoid arthritis;
• History of, or planned, hematopoietic stem cell transplantation;
• 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;
• Acute abdominal emergencies such as intestinal perforation or complete intestinal obstruction;
• Pregnant or potentially pregnant women, and lactating women;
• Poor treatment compliance.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruiiin Hospital Shanghai JiaoTong University School of Medicine

Shanghai, 200025, China

RECRUITING

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Hong-Lei Liu

CONTACT

+8617721375702; hong-lei-liu@163.com

Jiajia Hu

CONTACT

+8613524945287; hjj11592@rjh.com.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 3, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)