Study of Prednisone Treatment and Early Discontinuation in Adults With Idiopathic Retroperitoneal Fibrosis Using FDG-PETCT Scans

What this Trial Is About

This research focuses on adult patients diagnosed with idiopathic retroperitoneal fibrosis IRF to study the early discontinuation of steroid treatment in patients with negative FDG-PETCT scans. The study is a prospective multicenter cohort design assessing the effects of prednisone administered orally for 9 to 21 months. It aims to better understand IRF relapse rates after stopping steroids and the role of FDG-PETCT imaging in disease activity. Patients with positive FDG-PETCT scans receive oral prednisone at a starting dose of 1 mgkgday for one month, followed by a tapering schedule to reduce the dose below 10 mgday by six months and below 7.5 mgday by nine months. Those with negative FDG-PETCT results are excluded from the study. Follow-up visits are scheduled at 6, 9, 12, 15, and 21 months, with additional visits if relapse occurs. Treatment continuation or discontinuation after nine months depends on remission status and imaging results. Participants undergo clinical exams, blood and urine tests, abdominal CT scans, and FDG-PETCT imaging at baseline and during follow-ups. Researchers monitor symptoms, medication adherence, adverse events, and disease progression. The primary outcome is the cumulative IRF relapse rate 12 months after stopping steroids. The study includes safety assessments and analyzes changes in disease hypermetabolism over time, lasting until November 2028.

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