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

NCT ID: NCT07151521

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-07-01

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

ANCA-associated vasculitis with interstitial lung disease

No interventions assigned to this group

ANCA-associated vasculitis without interstitial lung disease

No interventions assigned to this group

ANCA-associated vasculitis with renal dysfunction

No interventions assigned to this group

ANCA-associated vasculitis without renal dysfunction

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruiiin Hospital Shanghai JiaoTong University School of Medicine

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hong-Lei Liu

Role: CONTACT

hong-lei-liu@163.com

+8617721375702

Jiajia Hu

Role: CONTACT

hjj11592@rjh.com.cn

+8613524945287

Facility Contacts

Hong-Lei Liu

Role: primary

hong-lei-liu@163.com

021-64370045

Other Identifiers

2025-432

Identifier Type: -

Identifier Source: org_study_id