RecruitingNot ApplicableNCT07104058

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


Sponsor

Luo Yaping

Enrollment

46 participants

Start Date

May 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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 Criteria1

  • ( 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.

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Interventions

DIAGNOSTIC_TEST68Ga-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.


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT07104058


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