A FEASIBILITY STUDY OF SGM-101, A FLUOROCHROME-LABELED ANTI-CARCINOEMBRYONIC ANTIGEN MONOCLONAL ANTIBODY FOR THE INTRAOPERATIVE DETECTION OF COLORECTAL BRAIN METASTASES
- Conditions
- Colorectal brain metastases100274761002921110009720
- Registration Number
- NL-OMON56091
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
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
resection.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method