NCT07104058 A Study on the Effect of MRD Detected by FAPI PET / CT on the Recurrence of IgG4-RD
| NCT ID | NCT07104058 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Luo Yaping |
| Condition | IgG4-Related Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2025-05-10 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 46 participants in total. It began in 2025-05-10 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. age 18-75 years old ; 2. Meet the 2019 ACR / EURLAR IgG4-RD diagnostic criteria ; 3. The disease was stable for more than 1 year, and the clinical evaluation of the disease was complete remission \* ; 4. 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 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.
Contact & Investigator
Yaping LUO, MD
PRINCIPAL INVESTIGATOR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT07104058 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying IgG4-Related Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07104058 currently recruiting?
Yes, NCT07104058 is actively recruiting participants. Contact the research team at luoyaping@live.com for enrollment information.
Where is the NCT07104058 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07104058 clinical trial?
NCT07104058 is sponsored by Luo Yaping. The principal investigator is Yaping LUO, MD at Peking Union Medical College Hospital. The trial plans to enroll 46 participants.