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临床试验/NL-OMON34705
NL-OMON34705已完成不适用

Cardiac sympathetic innervation imaging in patients with trastuzumab induced cardiotoxicity - CARIT

eids Universitair Medisch Centrum0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • Adult patients with confirmed HER-2 positive breast cancer (immunohistochemistry score 3 or fluorescence in-situ hybridization positive) who have completed local regional therapy and treatment with trastuzumab or are still on treatment with trastuzumab.
  • Permanent LVEF <=50% after treatment with trastuzumab, and/or
  • A permanent relative decrease of >=10% from baseline measured by means of echocardiography or MUGA scan and confirmed after 3 weeks after/during treatment with trastuzumab, and/or
  • Symptomatic congestive heart failure defined as NYHA class III/IV
  • Age 18-80 years.
  • Signed informed consent
  • Amendement: Add control group: patients without a permanent relative decrease of >=10% from baseline measured by means of echocardiography or MUGA scan and confirmed after 3 weeks after/during treatment with trastuzumab, and/or symptomatic congestive heart failure defined as NYHA class III/IV

排除标准

  • Pre-existing cardiac disease such as heart failure, ischemic and valvular heart disease, arrhythmia or poorly controlled hypertension.
  • Concomitant inflammatory disease.
  • Pregnancy/beast feeding.
  • Allergy against radiopharmaceutical (99m Tc-based tracer) for MUGA scan.

研究者

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