ANCA-associated VasculitisGFPIPWAAVNCT07151521
(68)Ga-FAPI PET/CT in Patients With ANCA-associated Vasculitis
An observational study of ANCA-associated Vasculitis, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ANCA-associated Vasculitis
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Jul 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in this study will be recruited from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruiiin Hospital Shanghai JiaoTong University School of Medicine
Shanghai, 200025
Hong-Lei Liu, 021-64370045, hong-lei-liu@163.com
About this study
Official title: Application Value of Novel PET Tracers Targeting CAF in 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.
- Conditions
- ANCA-associated Vasculitis
- Keywords
- ANCA-associated vasculitis, FAPI, PET/CT, ILD, Kidney
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ANCA-associated vasculitis with interstitial lung disease | Not described | |
| ANCA-associated vasculitis without interstitial lung disease | Not described | |
| ANCA-associated vasculitis with renal dysfunction | Not described | |
| ANCA-associated vasculitis without renal dysfunction | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease severity and activity in ANCA-associated vasculitis with concomitant interstitial lung disease and renal dysfunction as measured by 68Ga-FAPI PET/CT.
Measured: Within 4 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Sep 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANCA-associated VasculitisStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151521
- Sponsor's protocol ID
- 2025-432
- Acronym
- GFPIPWAAV
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The individual participant data will not be shared because the informed consent obtained from participants did not include permission for public data sharing, and institutional as well as ethical guidelines require strict protection of participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Value of Novel PET Tracers Targeting CAF in ANCA-Associated Vasculitis
- ClinicalTrials.gov ID
- NCT07151521
- Acronym / sponsor ID
- GFPIPWAAV / 2025-432
- Conditions
- ANCA-associated Vasculitis
- Keywords
- ANCA-associated vasculitis, FAPI, PET/CT, ILD, Kidney
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in this study will be recruited from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No. The individual participant data will not be shared because the informed consent obtained from participants did not include permission for public data sharing, and institutional as well as ethical guidelines require strict protection of participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ANCA-associated Vasculitis, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong-Lei Liu (+8617721375702, hong-lei-liu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.