A feasibility study of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody for the intraoperative detection of colorectal brain metastases.

Ki vehet részt

• Signed informed consent prior to any study-mandated procedure
• Patients aged over 18 years old
• 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
• Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions
• Diagnosed with brain metastasis of colorectal origin and scheduled for a resection

Ki nem vehet részt

• History of any anaphylactic reaction; 7. Previous use of SGM-101
• Previous use of SGM-101
• Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate)
• 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
• 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