NCT07104058

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Luo Yaping · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• IgG4-Related Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-10
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-08-05
• Last updated: 2025-08-05

Locations

1 site across 1 country: China