Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis

• Status: Not yet recruiting
• Trial end date: 2028-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Adult patients with a diagnosis of idiopathic retroperitoneal fibrosis Prospective multicentric cohort study Intervention : administration of prednisone during 9 to 21 months at 1mg/kg/day at inclusion.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Prednisone

Criteria

Inclusion Criteria:

• Patient over 18 years old

• Diagnosis of active idiopathic retroperitoneal fibrosis (IRF) defined by the association of:

• Related-disease symptoms (Appendix 17.2) or elevated CRP level (>20 mg/l) AND

• Retroperitoneal peri-aortic mass that surrounds the abdominal vessels on CT-scan

Exclusion Criteria:

• Secondary retroperitoneal fibrosis including drug-related retroperitoneal fibrosis, active infections (such as tuberculosis) or malignancies, systemic vasculitis (such as Anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis), Erdheim-Chester disease (Appendix 17.3),

• Relapse of an already treated IRF,

• Contraindication to perform FDG-PET/CT,

• Contraindication to perform CT scan with injection of contrast agent,

• Contraindication to treatment by prednisone

• Active infection

• Acute or chronic liver disease that is deemed sufficiently severe to impair their ability to participate in the trial,

• Active or history of malignancy in last 5 years. Individuals with squamous cell or basal cell skin carcinomas and individuals with cervical carcinoma in situ may be enrolled if they have received curative surgical treatment,

• Serum creatinine level greater than 400 µmol/L that cannot be attributed to underlying IRF,

• Live vaccination received from 4 weeks before inclusion,

• Inhaled glucocorticoids (except for patients with documented asthma),

• Any previous treatment with rituximab, methotrexate, alemtuzumab, cyclophosphamide, azathioprine, mycophenolate mofetil, infliximab, adalimumab, etanercept within the past 3 months,

• Pregnancy or breastfeeding,

• Non-affiliation to a social security regime,

• Subject deprived of freedom, subject under a legal protective measure

• Refusal to participate