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To investigate if the combination of fresh frozen sectioning based on cetuximab-800CW can enhance tumor-positive margin detection intra-operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 75mg cetuximab + 15mg cetuximab-800CW | Experimental | To investigate if study drugs can assist in tumor-positive margin detection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescence guided detection of tumor positive margins | Procedure | To test if the fluorescence can guide the location for fresh frozen section sampling intra-operatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enhanced intra-operative margin detection | To determine the feasibility of fluorescence imaging combined with fresh frozen sectioning of a fluorescence guided biopsy of the excised tissue specimen in an on-site intra-operative setting. Outcome parameter: Detection rate of tumor-positive margins based on standard of care histopathological H/E assessment compared to fresh-frozen section analysis combined with fluorescence | Postoperatively, i.e. 7-10 working days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Floris J Voskuil, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Max JH Witjes, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | Provincie Groningen | 9713 GZ | Netherlands |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
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| Cetuximab-IRDye800 | Drug | Administrate 75mg cetuximab + 15mg cetuximab-800CW for fluorescence visualization |
|
| D009375 |
| Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |