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临床试验/NCT03368989
NCT03368989已完成不适用

The Effects of Radium-223 Dichloride Therapy on Radionuclide Bone Scan Lesions.

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2014年2月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Change in number of osteoblastic bone lesions

研究概览

简要总结

To describe the changes seen on bone scan and correlate them with changes in relative chemical biomarkers, patient's functional status and level of pain.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Prostate cancer patients scheduled for treatment with Radium-223.

排除标准

  • •Patients not completing their treatment regimen for any reason

研究组 & 干预措施

treatment with radium-223 Dichloride (Xofigo)

干预措施: Radium-223 dichloride (Drug)

结局指标

主要结局

Change in number of osteoblastic bone lesions

时间窗: Pretreatment (about 30 days before treatment) and post treatment (about 4 weeks after treatment)

number of lesions specified before and after the treatment with a bone scan

次要结局

  • Hemoglobin level(pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments)
  • functional status as indicated by score on the Eastern Cooperative Oncology Group (ECOG) performance scale(Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments)
  • (ALP) alkaline phosphatase level(pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments)
  • pain level as assessed by numeric rating score(Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments)
  • Platelet level(pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments)
  • (PSA) prostate specific antigen level(pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments)
  • Neutrophil count(pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments)
  • Creatinine level(pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments)
  • white blood cell count(pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Isis W Gayed

Professor

The University of Texas Health Science Center, Houston

研究点 (1)

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