EUCTR2006-006380-22-DE进行中（未招募）1 期
Biological dosimetry in radiation synovectomy of small finger joints with Erbium [169Er] citrate - ER-MM1 biological dosimetry
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •(1) Age: at least 20 years
- •(2) Diagnosis of rheumatoid arthritis or seronegative spondylarthropathy by a physician with experience in rheumatologic/joint diseases (e.g., rheumatologist, orthopedist)
- •(3) Has at least one inflamed finger joint (MCP, PIP, DIP)
- •(4) Referred to RSO with Erbium [169Er] citrate of 1 finger joint (MCP, PIP, DIP) for clinical reasons
- •(5) Willingness to comply with the study procedures (e.g., follow-up visit at 45-50 days after RSO, having laboratory blood tests performed)
- •(6) Has personally provided written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •(1) No written informed consent
- •(2) Age below 20 years
- •(3) Women of child-bearing potential not using a reliable means of contraception
- •(4) Women, being pregnant or breast-feeding
- •(5) RSO of more than 1 joint planned
- •(6) Septic arthritis of the joint to be treated
- •(7) Local infection and disease of the skin in the vicinity of the injection site
- •(8) Intraarticular fracture
- •(9) Massive hemarthrosis
- •(10) Surgery of the joint to be treated within 50 days before or planned within 50 days after RSO
- •(11) Level of joint destruction higher than Steinbrocker radiological stage 3
- •(12) History of radiotherapy within 50 days before RSO or planned radiotherapy within 50 days after RSO
- •(13) History of chemotherapy within 50 days before RSO or planned chemotherapy within 50 days after RSO
- •(14) CT or x-ray fluoroscopy within 50 days before or after RSO (exception: fluoroscopy during the RSO procedure)
- •(15) Planned change of any immunosuppressive therapy within 50 days before or after RSO
- •(16) Any scintigraphy performed within 10 physical half-lives of the respective radionuclide before RSO or planned within 50 days after RSO
- •(17) Any radionuclide therapy started within 10 physical half-lives of the respective radionuclide before RSO or planned to be started within 50 days after RSO
- •(18) Already included in this or any other clinical study
- •(19) Uncooperative, in the investigator’s opinion
- •(20) Patients who are unable to give their informed consent personally
研究者
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