A Study on the Effect of MRD Detected by FAPI PET / CT on the Recurrence of IgG4-RD
ConditionIgG4-Related Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLuo Yaping
About this trial
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
This trial does not accept healthy volunteersQualifiers
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 )
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
68Ga-FAPI PET / CT
Diagnostic testIgG4-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.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: A(68Ga-FAPI PET / CT negative patients)Other 1 intervention
Group B: B(68Ga-FAPI PET / CT positive patients)Other 1 intervention
Trial outcomes
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.
Time frame
18 months after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Luo Yaping
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Peking Union Medical College Hospital
Collaborator
Source ClinicalTrials.gov