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临床试验/NCT00213642
NCT00213642终止不适用

Value of Tc-99m Renography for Early Diagnosis of Cisplatin-induced Renal Toxicity

University Hospital, Rouen0 个研究点目标入组 20 人开始时间: 2001年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
20

研究概览

简要总结

Cisplatin is a heavy-metal complex widely used in the treatment of a variety of malignancies, including small cell and non-small cell lung cancer, ovarian, bladder, head and neck, esophageal, cervical and germ cell tumors. The administration of cisplatin is commonly associated with certain drug-induced toxicities that may limit their clinical utility and adversely affect the quality of life of patients undergoing treatment. Although many advances have been made in reducing some of the toxicities associated with platinum drug therapy, it is clear that dose-limiting nephrotoxicity remains a major stumbling block in the use of this compound. Subtle changes in renal function occur without overt renal insufficiency, consisting of a decrease in effective renal plasma flow and tubular dysfunction despite aggressive hydratation. Early tubular damage occurring within 1 to 3 hours after cisplatin administration has been demonstrated by measurement of urinary beta 2-microglobulin, a sensitive marker of tubular injury. The chronic lesion has become of greater concern in recent years as many patients have been cured or placed into long-term remission due to cisplatin treatment. It consists of a decrease in glomerular filtration rate, which is not necessary characterized by a remarkable increase in serum creatinine. Cumulative tubular damage has been demonstrated by increased urinary excretion of tubular enzymes such as alanine aminopeptidase and beta 2-microglobulin. In this setting, predicting the occurrence of chronic cisplatin-induced nephrotoxicity remains a clinical challenge.

Tc-99m mercaptoacetyltriglycine (MAG3) is predominantly a proximal tubular secretion renal agent without cortical fixation indicated for dynamic renal studies to evaluate cortical tubular function and collecting system drainage. Tc-99m MAG3 and is the agent of choice for obstructive uropathy and diffuse functional abnormalities of the renal cortex. The aim of this study was to evaluate by means of Tc-99m MAG3 scintigraphy the acute and subacute impairment of tubular secretion after cisplatin administration in patients with head and neck cancer receiving chemotherapy.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with head and neck cancer
  • Receiving a chemotherapy including cisplatin administration (>80 mg/m2)
  • WHO score < or = 2
  • Estimated life expectancy > 6 month
  • Normal renal function
  • Signed informed consent

排除标准

  • Congestive heart failure
  • History of cisplatin treatment
  • Metastatic carcinoma
  • History of radiation therapy
  • History of renal insufficiency
  • History of chronic renal disease
  • Pregnancy

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

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