NL-OMON40272已完成2 期
A Phase 1, Open Label, Exploratory Study for the Intra-operative Imaging of Folate Receptor Alpha Positive Ovarian, Lung, Breast Cancer and Parathyroid adenomas using the Tumor Specific Imaging Agent EC17 - Intra-operative Imaging Ovarian, Lung, Breast Cancer, Parathyroid Adenomas
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
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
- •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;Breast cancer specific criterium
- •1. Primary diagnosis of primary breast cancer with FR-a positive tumor proven by biopsy planned for surgery;Parathyroid adenoma
- •1. Primary diagnosis of parathyroid adenoma planned for parathyroidectomy
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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