FAPI PET/CT to find tiny remaining IgG4‑RD lesions and guide treatment
Official title: A Prospective Study on the Effect of Minimal Residual Disease Detected by Fibroblast Activation Protein PET / CT on the Recurrence of IgG4-related Disease
Run by Peking Union Medical College Hospital · NCT07104058 · Data updated 2026-11-12
This trial will test whether a new 68Ga‑FAPI PET/CT scan can find tiny leftover disease and help decide whether adults with IgG4‑related disease in clinical remission need ongoing treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | methotrexate, prednisone |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | May 10, 2025 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | August 5, 2025 |
| Trial ID | NCT07104058 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 with confirmed IgG4‑RD who have been clinically in complete remission for ≥1 year and have negative 18F‑FDG PET/CT while on low‑dose prednisone (≤7.5 mg/day) or stable immunosuppressant doses are ideal candidates.
✕Probably not a fit
Patients with active disease, other connective tissue diseases, malignancy, pregnancy/planning pregnancy, active infections, severe irreversible organ damage, or recent relapse are unlikely to benefit and are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective randomized study enrolling adults with IgG4‑RD who have been in clinical complete remission for at least one year and have negative 18F‑FDG PET/CT after therapy. All participants receive a 68Ga‑FAPI PET/CT scan and are stratified as MRD‑negative (FAPI‑) or MRD‑positive (FAPI+). MRD‑negative patients stop treatment and are observed, while MRD‑positive patients are randomized to either low‑dose glucocorticoid ± immunosuppressant maintenance or treatment withdrawal, with only endpoint assessors blinded. Participants are followed for 18 months with quarterly clinical assessments to document relapse rates.
Why it matters
Potential benefit: If successful, this could let doctors detect hidden residual disease and tailor maintenance therapy to reduce relapses.
How similar studies have gone: FAPI PET/CT is an emerging imaging tool that has shown promise in detecting fibrotic or inflammatory lesions in other conditions, but using it to predict relapse in IgG4‑RD is novel and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age 18-75 years old ; 2. Meet the 2019 ACR / EURLAR IgG4-RD diagnostic criteria ; 3. The disease was stable for more than 1 year, and the clinical evaluation of the disease was complete remission \* ; 4. 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.
Where it's running
-
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Yaping LUO, MD — Peking Union Medical College Hospital
- Study coordinator: Yaping Luo, MD
- Email: luoyaping@live.com
- Phone: 86-010-69154716
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.