EUCTR2015-000535-33-NL进行中（未招募）不适用
Phase II, Open-Label Study to Evaluate Safety and Explore Efficacy of Escalating Doses of Bevacizumab-IRDye800CW as an Optical Imaging Agent to Detect Cancer Tissue Delineation During Tumor Resection Surgery in Patients with Breast Cancer - Breast-cancer Fluorescence Guided Surgery
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
- •1.Male or Female, aged = 18 years.
- •2.Confirmed diagnosis of breast cancer by means of histology or cytology and eligible for tumor resection surgery.
- •3.Tumor size = 5 mm (0, 5 cm) diameter according to anatomical imaging data.
- •4.WHO performance score 0-2.
- •5.Life expectancy greater than 12 weeks
- •6.Written informed consent has been obtained
- •7.In the Investigator’s opinion, patient is able and willing to comply with all trial requirements.
- •For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post menopausal
- •8.A negative serum pregnancy test within 2 weeks prior to receiving the second generation tracer
- •9.Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.
- •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 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 27
排除标准
- •1.Non palpable breast tumor
- •2.Breast prosthesis in the target breast
- •3.History of infusion reactions to Bevacizumab or other monocolonal antibody therapies
- •4.Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last 6 weeks prior to the start of the treatment
- •5.Unresolved chronic non-hematological toxicity higher than NCI-CTC grade 2
- •6.Participation in a clinical study involving an investigational drug or device within 30 days prior to the start of treatment
- •7.Significant renal or hepatic impairment.
- •8.Scheduled elective surgery, with the exception of the breast surgical procedure, or other procedures requiring general anaesthesia during the trial.
- •9.Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
- •10.Inadequately controlled hypertension with or without current antihypertensive medications.
- •11.History of MI, TIA, CVA, pulmonary embolism, uncontrolled CHF, significant liver disease, unstable angina within 6 months prior to enrolment.
- •12.Patients receiving anticoagulant therapy with vitamin K antagonists.
- •13.Patients receiving Class IA or Class III antiarrhythmic agents.
- •14.Evidence of QT prolongation on pre treatment ECG (males >440ms, females>450 ms)
- •15.Magnesium, potassium and calcium levels below LLN which is regarded clinically relevant with regards to study participation.
研究者
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