ClinicalTrials.gov record NCT07104058
A Study on the Effect of MRD Detected by FAPI PET / CT on the Recurrence of IgG4-RD
A Prospective Study on the Effect of Minimal Residual Disease Detected by Fibroblast Activation Protein PET / CT on the Recurrence of IgG4-related Disease
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This study looks at whether tiny residual lesions seen on 68Ga-FAPI PET/CT are related to later recurrence in people with IgG4-related disease who are in clinical complete remission after treatment and have negative 18F-FDG PET/CT. All participants will receive a 68Ga-FAPI PET/CT scan; those without FAPI uptake will stop treatment and be observed. Participants with FAPI-positive findings will be randomized to either continue low‑dose glucocorticoids (with or without an immunosuppressant) or stop treatment, and all are followed for 18 months with quarterly checks for relapse.
What it is studying. Whether minimal residual disease (MRD) detected by 68Ga-FAPI PET/CT is associated with later recurrence of IgG4-related disease, and—among MRD-positive people—how continuing low-dose glucocorticoid maintenance (with or without immunosuppressant) compares with stopping treatment in terms of recurrence over 18 months.
What the researchers hope to learn. To find out whether 68Ga-FAPI PET/CT can detect minimal residual disease that predicts recurrence of IgG4-related disease, and to compare recurrence rates in MRD-positive patients who continue maintenance therapy versus those who stop treatment over an 18-month period.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This study intends to use the new technology of fibroblast activation protein PET / CT to study whether the tiny residual lesions detected by 68Ga-FAPI PET / CT are related to the recurrence of IgG4-RD in patients with IgG4-RD who have been clinically evaluated for complete remission after treatment.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Diagnostic test
- 68Ga-FAPI PET / CT
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- age 18-75 years old ;
- Meet the 2019 ACR / EURLAR IgG4-RD diagnostic criteria ;
- The disease was stable for more than 1 year, and the clinical evaluation of the disease was complete remission * ;
- Glucocorticoid dosage ≤ prednisone 7.5mg / d × 6 months or more, or combined with an immunosuppressive therapy ( mycophenolate mofetil ) Ester ≤ 1.0g / d, leflunomide ≤ 20mg / d, methotrexate ≤ 15mg / w, azathioprine ≤ 100mg / d, iguratimod ≤ 25mg Bid )
Exclusion criteria
- ( 1 ) Combined with other connective tissue disease patients ( 2 ) patients with tumor ; ( 3 ) women during pregnancy or planning pregnancy ; ( 4 ) active infection, including HIV, HCV, HBV, TB, etc. ; ( 5 ) Severe irreversible organ damage ; ( 6 ) In the active stage of the disease, the IgG4-RD reaction index score of the single affected organ was 2 points ; ( 7 ) stable condition less than 1 year ; ( 8 ) patients who relapsed within 1 year of previous hormone reduction and withdrawal ; ( 9 ) Combination of two or more immunosuppressive agents.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
This prospective randomized controlled study will enroll IgG4-RD patients who have achieved clinical complete remission with negative 18F-FDG PET/CT findings after glucocorticoid and immunosuppressant therapy. Following enrollment, all participants will undergo 68Ga-FAPI PET/CT screening.Based on the results, patients will be stratified into two groups: Group A (68Ga-FAPI PET/CT negative, indicating MRD-negative status) and Group B (68Ga-FAPI PET/CT positive, indicating MRD-positive status). Group A (MRD-negative) will receive no intervention and enter treatment withdrawal with observational follow-up. Group B (MRD-positive) patients will be randomized 1:1 into either the experimental subgroup B1 (continuing low-dose glucocorticoids with or without immunosuppressant maintenance therapy) or the control subgroup B2 (treatment withdrawal with observational follow-up). All participants will be followed for 18 months with quarterly clinical disease activity assessments to document relapse. Randomization will be performed using an online randomization system, with only the endpoint assessors blinded to group allocation while other investigators and study subjects remain aware of the randomization results.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
All enrolled participants will have a 68Ga‑FAPI PET/CT scan. Those with a negative FAPI scan will stop treatment and be followed without intervention; those with a positive FAPI scan will be randomized 1:1 to either continue low‑dose glucocorticoids (with or without a single immunosuppressant) or to stop treatment and be observed. Clinical disease activity will be assessed every 3 months, and all participants are followed for 18 months to document recurrence. Randomization uses an online system; only endpoint assessors are blinded to group assignment.
How the study is structured. Interventional study with a diagnostic focus. All enrolled participants undergo a 68Ga-FAPI PET/CT scan. Based on the scan they are placed into two groups: FAPI-negative (no further treatment, observational follow-up) or FAPI-positive. FAPI-positive participants are randomized 1:1 to either continue low-dose glucocorticoids (± immunosuppressant) or withdraw treatment. Follow-up lasts 18 months with clinical assessments every three months. Endpoint assessors are blinded; other staff and participants are not.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on IgG4-related disease
Important dates
- Study start
- May 10, 2025
- Primary completion
- Dec 1, 2027 (estimated)
- Study completion
- Dec 1, 2027 (estimated)
- Target enrollment
- 46 participants (estimated)
- Last updated on registry
- Aug 5, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Luo Yaping
- Collaborators
- Peking Union Medical College Hospital
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Yaping Luo, MD 📞 86-010-69154716 ✉ luoyaping@live.com
Participating sites (1)
- Peking Union Medical College HospitalRecruiting
Beijing, Beijing Municipality, 100730 · China
- Jiayue Li · 86-010-69156874 · xs@abscd.com
Terms used on this page · explanations by MedicalUpdates.ai
- PET
- A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
- CT
- An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
- complete remission
- No sign of the condition can be found with the tests used in the study. It does not always mean the condition is gone permanently, and the definition depends on the condition and the study.
- Glucocorticoid
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- relapsed
- A condition that improved with treatment and has since returned or worsened.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- stratified
- Randomisation done separately within subgroups, such as age bands or disease severity, so that each group contains a similar mix.
- MRD-negative
- Very small amounts of disease that remain after treatment and can only be found with highly sensitive tests. 'MRD-negative' means none was detected at the test's limit. The exact test and threshold depend on the condition and the study.
- no intervention
- A study group that does not receive the intervention being tested and is observed for comparison.
- observational
- A study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- 1:1
- How many participants go to each group. In a 2:1 ratio, two are assigned to the first group for every one assigned to the second.
- endpoint
- Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
- blinded
- Who does not know which intervention a participant is receiving. It can apply to participants, the people giving the treatment, those assessing results, or those analysing the data.
- allocation
- How participants are assigned to study groups, for example at random or by a non-random rule.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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