An interventional study of 68Ga-FAPI PET / CT in IgG4-Related Diseases, sponsored by Luo Yaping. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-05.
Sponsored by Luo Yaping · Not applicable, Interventional, and Diagnostic
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.
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.
67 studies on the registry are indexed under Immunoglobulin G4-Related Disease; 36 are open to participants now.
This study's planned enrollment of 46 is close to the median of 46 across 48 interventional studies indexed under Immunoglobulin G4-Related Disease.
Browse Immunoglobulin G4-Related Disease studies →Luo Yaping is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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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.
Group A (MRD-negative) will receive no intervention and enter treatment withdrawal with observational follow-up.
Diagnostic Test: 68Ga-FAPI PET / CT
Group B (68Ga-FAPI PET/CT positive, indicating MRD-positive status). 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).
Diagnostic Test: 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.
Recurrence rate of IgG4-related disease.
All participants will be followed for 18 months with quarterly clinical disease activity assessments to document relapse.
Time frame: 18 months after enrollment
Plan to share: No
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