NL-OMON56091尚未招募2 期
A FEASIBILITY STUDY OF SGM-101, A FLUOROCHROME-LABELED ANTI-CARCINOEMBRYONIC ANTIGEN MONOCLONAL ANTIBODY FOR THE INTRAOPERATIVE DETECTION OF COLORECTAL BRAIN METASTASES - SGM-101 in colorectal brain metastases
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 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
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed informed consent prior to any study-mandated procedure;
- •2. Patients aged over 18 years old;
- •3. All women of child bearing potential and all males must practice effective
- •contraception during the study and be willing and able to continue
- •contraception for at least 30 days after their last dose of study treatment.
- •4. Has the ability to communicate well with the Investigator in the Dutch
- •language and willing to comply with the study restrictions.
- •5. Diagnosed with brain metastasis of colorectal origin and scheduled for a
排除标准
- •6. History of any anaphylactic reaction;
- •7. Previous use of SGM-101;
- •8. Other malignancies either currently active or diagnosed in the last 5 years,
- •except adequately treated in situ carcinoma of the cervix and basal or squamous
- •cell skin carcinoma;
- •9. Patients pregnant or breastfeeding (pregnancy should be ruled out by a
- •pregnancy test within two weeks prior to administration of the conjugate);
- •10. Any condition that the investigator considers to be potentially
- •jeopardizing the patient*s well-being or the study objectives (following a
- •detailed medical history, physical examination, vital signs (systolic and
- •diastolic blood pressure, pulse rate, body temperature) and 12-lead
- •electrocardiogram (ECG)). Minor deviations from the normal range may be
- •accepted, if judged by the Investigator to have no clinical relevance.
研究者
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