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Clinical Trials in China / NCT07104058
Recruiting Not applicable

A Study on the Effect of MRD Detected by FAPI PET / CT on the Recurrence of IgG4-RD

NCT07104058 · tracked via the Priya Life Science China tracker
Sponsor
Luo Yaping
Phase
Not applicable
Started
2025-05-10
Last updated
2025-08-05

Condition(s) studied

IgG4-Related Diseases

Investigational drug(s) / intervention(s)

68Ga-FAPI PET / CT

68Ga-FAPI PET / CT: IgG4-RD patients with clinical complete remission after hormone and immunosuppressive therapy and 18F-FDG PET / CT negative were included. After enrollment, 68Ga-FAPI PET / CT screening was performed.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07104058 on ClinicalTrials.gov ↗ ← All trials in China