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| Name | Class |
|---|---|
| Erasmus Medical Center | OTHER |
| Surgimab | INDUSTRY |
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Near-infrared fluorescence-guided oncologic surgery (FGOS) with the use of a tumor specific tracer (SGM-101) developed by Surgimab can provide valuable intra-operative information about tumor location and extensiveness. SGM-101 already proven to be safe and valuable in colorectal cancer.
This study aims to prove feasibility for colorectal lung metastases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGM-101 | Experimental | Patients included with colorectal lung metastases, SGM-101 7.5-12.5mg, 3-5 days prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGM-101 | Drug | Fluorescence guided surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability of SGM-101 and a near-infrared camera system to detect colorectal lung metastases. | Intraoperative imaging of colorectal lung metastases based on the tumor-to-background ratio | peroperative |
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Inclusion Criteria:
Exclusion Criteria:
History of any anaphylactic reaction;
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 (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate);
Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
Previous SGM-101 use
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Vahrmeijer | Contact | 071 526 9111 | a.l.vahrmeijer@lumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Recruiting | Leiden | South Holland | 2333 ZA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37552367 | Derived | Meijer RPJ, Galema HA, Faber RA, Bijlstra OD, Maat APWM, Cailler F, Braun J, Keereweer S, Hilling DE, Burggraaf J, Vahrmeijer AL, Hutteman M; SGM-CLM study group. Intraoperative molecular imaging of colorectal lung metastases with SGM-101: a feasibility study. Eur J Nucl Med Mol Imaging. 2024 Aug;51(10):2970-2979. doi: 10.1007/s00259-023-06365-3. Epub 2023 Aug 8. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Prospective inclusion patients with colorectal lung metastases. Al injected with SGM-101.
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| Erasmus Medical Center | Not yet recruiting | Rotterdam | Netherlands |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |