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| ID | Type | Description | Link |
|---|---|---|---|
| 2019/2886 | Other Identifier | CSET number |
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Assess the sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after a complete macroscopic surgical resection of head and neck cancers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with head and neck cancer | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indocyanine green | Drug | indocyanine green (INFRACYANINE© 25mg/10mL). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Near Infrared Fluorescence Imaging | Sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after complete macroscopic surgical resection. For the calculation of the sensitivity, for each operating room we consider the first section and the last section in which the pathological analysis confirms the presence of microscopic residual disease. Patients for whom near-infrared fluorescence imaging detects disease are classified as true positives (TP). Sensitivity is defined as the number of TP divided by the total number of patients N. | at surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe Gorphe, MD | Contact | +33 (0)1 42 11 42 11 | philippe.gorphe@gustaveroussy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Recruiting | Anderlecht | 1070 | Belgium |
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Prospective non-randomized bicentric study
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| Gustave Roussy | Recruiting | Villejuif | Val De Marne | 94800 | France |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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