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NCT Number: NCT07151521

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

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.

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Key information

Conditions

ANCA-associated Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Cardiovascular Diseases Immune System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruiiin Hospital Shanghai JiaoTong University School of Medicine

Shanghai, 200025, China

Location status: Recruiting

Location contact

Hong-Lei Liu

CONTACT

[email protected]

021-64370045

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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

Time frame: Within 4 weeks after enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Hong-Lei Liu

CONTACT

[email protected]

+8617721375702

Jiajia Hu

CONTACT

[email protected]

+8613524945287

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Acronym: GFPIPWAAV

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Sep 3, 2025
Registry last updated: Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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