NL-OMON34945尚未招募2 期
A phase II, open label, non-randomized, multi-center, pilot, efficacy study of [F-18]RGD-K5 positron emission tomography (PET) as a tool to monitor response to an anti-angiogenic drug - [F-18]RGD-K5
Siemens Molecular Imaging Biomarker Research0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
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
- •Patient is >18 years and male or female of any race / ethnicity
- •Patient provides written informed
- •consent and willing to comply with protocol requirements
- •Patient must be scheduled to receive chemotherapy treatment(s) plus Avastin® for
- •their cancer care; treatment management will be made by treating medical oncologists (According to the package insert for Avastin®, it is administered as an IV infusion every 3 weeks for non-squamous non-small cell lung cancer, and every 2 weeks for metastatic breast cancer, colon or rectum cancer)
- •Patient will be scheduled to have a clinical [F-18] FDG-PET/CT or diagnostic CT pretreatment, and after the fourth but before the fifth Avastin® treatment
排除标准
- •Patient is not capable of complying with study procedures
- •Female patient is pregnant or nursing
- •Patient has a severe hepatic or renal disease as defined by previous medical history or abnormal renal and hepatic functions determined by lab results not within the following ranges, or in the opinion of the Investigator, the values are not acceptable for the patient to be included:
- •o AST (SGOT)/ALT (SGPT) <= 2.5 x institutional upper limits of normal
- •o Serum creatinine <= 2x institutional upper limits of normal
- •o BUN within 2x institutional upper limits of normal
- •Patient has known hyper or hypo-coagulation syndromes. (e.g. Protein C, S deficiency, Hemophilia A/B/C, Factor-V Leiden, etc) or lab results are not within the following ranges, or in the opinion of the Investigator, the values are not acceptable for the patient to be included:
- •o Platelet counts of < 75 x 103/µL
- •Patient has known sensitivity to any components of Avastin® such as recombinant
- •human or humanized antibodies
- •Patient has been involved in an investigative, radioactive research procedure or within 7 days and during the study participation period
- •Patient will participate in experimental therapy procedures while participating in this clinical trial
- •Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality to achieve study objectives, or complete study and/or post-dose follow-up examinations
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