Multicentre Canadian Study to Measure the Safety and Efficacy of Synoviorthesis Performed With Yttrium-90 or Rhenium-186 Sulfide
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 9
- 主要终点
- safety
研究概览
简要总结
Radiation synovectomy by intra-articular injection of beta-emitting radionuclides is considered a reliable and easy-to-perform therapy without harmful side-effects for the treatment of inflammatory joint disease in many countries.
The goal of this study is to demonstrate Yttrium-90 citrate colloid or Rhenium-186 sulfide synovectomy are appropriate therapeutic interventions in patients with persistent active synovitis of a joint (characterized by pain, tenderness, and effusion) which is resistant to systemic therapy and intra-articular corticosteroid injections.
The primary objective will be to assess the safety of an intra-articular administration of Yttrium-90 citrate colloid or Rhenium-186 sulfide.
The secondary objective will be to assess the efficacy on synovitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •There is no age limit for RSO
- •Patient referred by a medical joint specialist (orthopedist, rheumatologist or internal medicine in the absence of local joint specialist)
- •Patient having a refractory inflammatory articular disease:
- •Failure of medical therapy after 6 months
- •Clinical signs of an active mono or oligo synovitis
- •Joint X-ray, echo or MR showing minimal cartilage or bone destruction
- •Pain limits normal activities or requires significant analgesic medication
排除标准
- •Prior RSO within last 3 months in that joint
- •Collapse of the articular plateau or intra-articular fracture
- •Surgery or arthroscopy within last 6 weeks
- •Painful prosthesis
- •Joint infection, local skin infection, bacteremia
- •Joint puncture within last 2 weeks (increased risk of soft tissue necrosis along the needle track)
- •Pregnancy or breast feeding
- •Synovial cyst rupture
- •Massive hemarthrosis
- •Generalized synovitis defined as more than 5 uncontrolled joints by clinical examination or 3 phases bone scan
- •Surgical synovectomy within 6months
- •Cancer with bone metastases
- •Hypersensitivity, allergies or contraindication to the used radiopharmaceutical agent
- •Participation in any other ongoing clinical trial for the underlying inflammatory condition
研究组 & 干预措施
radiosynoviorthesis with yttrium-90 or rhenium -186
Patients suffering from arthritis or chronic inflammatory joint disease.
干预措施: Radiosynoviorthesis (Drug)
结局指标
主要结局
safety
时间窗: 3-4 days post -treatment
The safety profile will be assessed by the incidence of AEs. All the AEs will be described by system/organ class and preferred terms and overall sorted by frequency.
次要结局
- Efficacy(Clinical response post treatment)
研究者
Dr Éric E Turcotte, MD
Head, Clinical research, Centre d'imagerie moléculaire de Sherbrooke; Associate Professor, Université de Sherbrooke;Nuclear Medecine Specialist
Centre de recherche du Centre hospitalier universitaire de Sherbrooke