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| Name | Class |
|---|---|
| Medical Center Haaglanden | OTHER |
| Surgimab | INDUSTRY |
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This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with colorectal brain metastases | Experimental | 10 mg SGM-101, administration 3 to 5 days prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGM-101 | Drug | Fluorescence-guided surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases. |
| Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
History of any anaphylactic reaction;
Previous use of SGM-101;
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;
Laboratory abnormalities defined as:
Patients pregnant or breastfeeding;
Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mats Warmerdam, MD | Contact | +31 71 5265 401 | m.i.warmerdam@lumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Recruiting | Leiden | 2333 ZA | Netherlands |
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| Medical Center Haaglanden | Recruiting | The Hague | 2512 VA | Netherlands |
|
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D001932 | Brain Neoplasms |
| D001927 | Brain Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D012002 | Rectal Diseases |
| D003108 | Colonic Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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