2024-514353-30-00RecruitingPhase 4
METRO Early discontinuation of steroid treatment in negative FDG-PET/CT patients with idiopathic retroperitoneal fibrosis. A prospective multicentric study
Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris8 sites in 1 country41 target enrollmentStarted: July 30, 2024Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 41
- Locations
- 8
- Primary Endpoint
- The primary endpoint is the cumulate IRF relapse rate measured at the end of the study (M21). The diagnosis of IRF relapse is based on the association of a clinical or biological criterion with a radiological criterion (i.e. composite criteria):
Study Overview
Brief Summary
To compare the cumulative IRF relapse rate 12 months after discontinuation of steroids.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient over 18 years old
- •New onset or untreated relapsing of active idiopathic retroperitoneal fibrosis (IRF) defined by the association of: o Related-disease symptoms (Appendix 17.2) or elevated CRP level (>20 mg/l) AND o 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 ANCA-associated vasculitis), Erdheim-Chester disease (Appendix 17.3), patients with IgG4 disease may be enrolled
- •Inhaled glucocorticoids (except for patients with documented asthma),
- •Any previous treatment with rituximab, methotrexate, alemtuzumab, cyclophosphamide, azathiorpine, 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
- •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,
Outcomes
Primary Outcomes
The primary endpoint is the cumulate IRF relapse rate measured at the end of the study (M21). The diagnosis of IRF relapse is based on the association of a clinical or biological criterion with a radiological criterion (i.e. composite criteria):
The primary endpoint is the cumulate IRF relapse rate measured at the end of the study (M21). The diagnosis of IRF relapse is based on the association of a clinical or biological criterion with a radiological criterion (i.e. composite criteria):
Secondary Outcomes
- 1. a. Visual grades of retroperitoneal fibrosis FDG uptake as compared to liver FDG uptake (which consist of one item that yields a score of 0 to III), maximal standardized uptake value (SUVmax) within the retroperitoneal fibrosis (regions of interest- ROI) at diagnosis (M0), remission (M9), M21 and relapse, b. Metabolic volume (i.e. ratio of metabolically active volume (MAV) to global lesion volume) of retroperitoneal fibrosis FDG uptake at diagnosis (M0), remission (M9), M21 and relapse,
- 2. Diagnostic performance of SUVmax and MAV (area under the curve (AUC) and performance values for the Youden index) for the disease activity,
- 3. Frequency of diabetes, severe infection, osteoporotic fracture and major cardiovascular events 12 months after remission (M21). Serious cardiovascular adverse events are defined as a composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death and will be assessed at M12,M15 and M21
Investigators
SACRE Karim
Scientific
Assistance Publique Hopitaux De Paris
Study Sites (8)
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