2024-514353-30-00招募中4 期
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 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2024年7月30日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 41
- 试验地点
- 8
- 主要终点
- 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):
研究概览
简要总结
To compare the cumulative IRF relapse rate 12 months after discontinuation of steroids.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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,
结局指标
主要结局
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):
次要结局
- 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
研究者
SACRE Karim
Scientific
Assistance Publique Hopitaux De Paris
研究点 (8)
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