EUCTR2013-004089-33-NL进行中（未招募）不适用
A Phase 1, Open Label, Exploratory Study for the Intra-operative Imaging of Folate Receptor Alpha Positive Ovarian and Lung Cancer using the Tumor Specific Imaging Agent EC17
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •General Inclusion Criteria
- •1.Subjects 18 years of age and older
- •2.Normal and clinically acceptable medical history, medical physical examination and vital signs at screening
- •3.Patients are clinically fit for surgery
- •4.Absence of anaphylactic reactions to EC17 or insects or allergy to fluorescein
- •5.No pregnancy, excluded by pregnancy test
- •6.The patients screening ECG and clinical laboratory test results are within normal range or are clinically insignificant
- •7.Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •8.Before patient registration, written informed consent must be given
- •9.No impaired renal or liver function. Impaired renal function defined as eGFR<50 and impaired liver function defined as evidenced by greater than 3x the upper limit of normal (ULN) for ALT, AST, or total bilirubin.
- •Lung Cancer Specific Inclusion Criteria
- •1.Primary diagnosis of primary NSCLC lung cancer with FR-a positive tumor proven by biopsy planned for surgery
- •2.No previous thorax surgery, except for mediastinoscopy
- •3.No previous radiation therapy for lung cancer
- •Ovarian Cancer Specific Inclusion Criterium
- •1.Known or high clinical suspicion of primary ovarian cancer planned for either primary debulking surgery , intervaldebulking or staging procedure
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1.Any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient
研究者
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