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

NCT07104058 | Recruiting

• 2 other identifiers: FAPI-IgG4RDCategoty C, UBJ10707
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IgG4-Related Diseases

Keywords

IgG4-Related Diseases; FAPI PET/CT

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

A(68Ga-FAPI PET / CT negative patients)

OTHER

Group A (MRD-negative) will receive no intervention and enter treatment withdrawal with observational follow-up.

Diagnostic Test: 68Ga-FAPI PET / CT

B(68Ga-FAPI PET / CT positive patients)

OTHER

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

Interventions

68Ga-FAPI PET / CT DIAGNOSTIC_TEST

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.

A(68Ga-FAPI PET / CT negative patients); B(68Ga-FAPI PET / CT positive patients)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 )

You may not qualify if:

• ( 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.

Sponsors & Collaborators

• Luo Yaping: lead
• Peking Union Medical College Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Study Officials

• Yaping LUO, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaping Luo, MD

CONTACT

86-010-69154716; luoyaping@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor (M.D.), Chief Physician, Professor, Assistant Director

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: August 5, 2025
• Study Start: May 10, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)