Actively Recruiting
Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis A Prospective Multicentric Study
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-05-25
41
Participants Needed
15
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
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-PET/CT 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-PET/CT imaging in disease activity. Patients with positive FDG-PET/CT scans receive oral prednisone at a starting dose of 1 mg/kg/day for one month, followed by a tapering schedule to reduce the dose below 10 mg/day by six months and below 7.5 mg/day by nine months. Those with negative FDG-PET/CT 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-PET/CT 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.
CONDITIONS
Brief Title
Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years old
- New onset or untreated relapsing of active idiopathic retroperitoneal fibrosis
- Presence of related disease symptoms or elevated CRP level (>20 mg/l)
- Retroperitoneal peri-aortic mass surrounding abdominal vessels on CT scan
You will not qualify if you...
- Secondary retroperitoneal fibrosis including drug-related causes, active infections, malignancies, systemic vasculitis, or Erdheim-Chester disease
- Contraindications to FDG-PET/CT or CT scan with contrast
- Contraindications to prednisone treatment
- Active infection
- Severe acute or chronic liver disease
- Active or history of malignancy within last 5 years except treated skin or cervical carcinoma in situ
- Serum creatinine >400 µmol/L not due to IRF
- Live vaccination within 4 weeks before inclusion
- Use of inhaled glucocorticoids except for asthma patients
- Previous treatment with specific immunosuppressants within past 3 months
- Pregnancy or breastfeeding
- Not affiliated with social security
- Subject deprived of freedom or under legal protection
- Refusal to participate
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 9 to 21 months
Participants receive oral prednisone starting at 1mg/kg/day for 1 month, followed by a tapered dose to less than 10mg/day at 6 months and less than 7.5mg/day at 9 months based on clinical response and imaging.
Visits at months 6, 9, 12, 15, and 21; additional visits at relapse
Duration - Up to 12 months after treatment discontinuation
Participants who achieve remission at 9 months may discontinue steroids and are monitored for relapse and adverse events with clinical examinations, imaging, and biological tests.
Follow-up visits at months 12, 15, 21, and at relapse
Trial Site Locations
Total: 15 locations
1
Médecine Interne
Agen, France, France, 47000
Actively Recruiting
2
Médecine interne
Brest, France, France, 29200
Actively Recruiting
3
Médecine interne et maladies infectieuses - GH Sud Haut Lévêque
Bordeaux, France, 33604
Actively Recruiting
4
Médecine interne - Ambroise Paré
Boulogne-Billancourt, France, 92100
Actively Recruiting
5
Médecine interne - Henri-Mondor
Créteil, France, 94000
Actively Recruiting
6
Médecine interne et immunologie clinique - Dijon
Dijon, France, 21000
Actively Recruiting
7
Médecine interne - Lille
Lille, France, 59000
Active, Not Recruiting
8
Médecine Interne - La Timone
Marseille, France, 13005
Actively Recruiting
9
Médecine interne - Saint Antoine
Paris, France, 75012
Actively Recruiting
10
Médecine Interne, Vascularites et Myosites - La Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
11
Médecine interne - Cochin
Paris, France, 75014
Actively Recruiting
12
Médecine vasculaire - HEGP
Paris, France, 75015
Actively Recruiting
13
Médecine Interne - Bichat
Paris, France, 75018
Actively Recruiting
14
Néphrologie - Bichat
Paris, France, 75018
Active, Not Recruiting
15
Médecine interne - Delafontaine
Saint-Denis, France, 93200
Active, Not Recruiting
Research Team
K
Karim SACRE
K
Khadija BENALI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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