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 study identifier
Secondary identifiers
OTHER_GRANT · PekingUMCH Talent Cultivation Program
interventional
46
1 country
1
Study Start
May 10, 2025
Actual (reported)Primary Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 7, 2025
Actual (reported)May 10, 2025
Actual (reported)August 5, 2025
Actual (reported)December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Recurrence rate of IgG4-related disease.
All participants will be followed for 18 months with quarterly clinical disease activity assessments to document relapse.
18 months after enrollment
Group A (MRD-negative) will receive no intervention and enter treatment withdrawal with observational follow-up.
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).
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Yaping LUO, MD
Peking Union Medical College Hospital
First Submitted
May 7, 2025
First Posted
August 5, 2025
Study Start
May 10, 2025
Actual (reported)Primary Completion
December 1, 2027
EstimatedStudy to Evaluate the Efficacy and Safety of CM310 in Subjects With IgG4-related Disease
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 5, 2025
Record last verified: 2025-08
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Source: ClinicalTrials.gov.
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