跳至主要内容
临床试验/NL-OMON46831
NL-OMON46831撤回不适用

Qualification of imaging methods to assess cancer drug induced interstitial lung disease (ImageILD) - EORTC-1658-IG

European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 5 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
撤回
发起方
入组人数
5

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

  • * Age * 18 years
  • * WHO performance status 0-2
  • * Life expectancy > 6 months
  • * Proven cancer diagnosis in a patient actively undergoing systemic anticancer
  • * New onset symptoms (e.g. cough, fever, dyspnoea, and hypoxia) at any
  • time during or within 4 weeks of the last dose of anti-cancer treatment
  • * New onset radiological (CXR or CT) abnormalities within the lungs at any
  • time during or within 4 weeks of the last dose of anti-cancer treatment
  • (e.g. diffuse lung changes, infiltrative opacification in the periphery of the
  • lung or ground glass changes) with a locally reviewed diagnosis of DIILD as
  • the most likely explanation for the radiological abnormalities.
  • * Treatment for DIILD planned (e.g. drug withdrawal, interruption +/-
  • supportive therapy including corticosteroids, oxygen, bronchodilators etc.).
  • Treatment with antibiotics, anticoagulants etc. is permitted pending results
  • of investigations for differential diagnoses.
  • * Able to undergo pulmonary function tests (at a minimum spirometry and
  • gas transfer (DLCO))
  • * Patients enrolled on other anti-cancer investigational trials are permitted
  • at investigator discretion
  • * Informed written consent obtained according to ICH/GCP, and
  • national/local regulations
  • * Women of child bearing potential (WOCBP) must have a negative serum (or
  • urine) pregnancy test within 14 days before study registration

排除标准

  • * Primary lung tumor greater than 3cm
  • * Lung metastatic lesion > 2cm or greater than 5 metastases
  • * Claustrophobia, or inability to undergo non-contrast CT examination
  • * Known or suspected non-drug related ILD (e.g. lung abnormalities due to
  • other causes such as occupational exposure)
  • * Previous thoracic lobectomy
  • * Clinical, radiological or microbiological evidence of active lower respiratory
  • tract infection
  • * Currently active, clinically significant heart disease, such as uncontrolled
  • class 3 or 4 congestive heart failure defined by the New York Heart
  • Association Functional Classification
  • * Any medical, psychological, sociological or geographical condition that
  • could affect participation in the study and compliance with the study

研究者

发起方
European Organisation for Research in Treatment of Cancer (EORTC)

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