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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
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This is a prospective single-center interventional non-inferiority study where subjects are participating for one day for patients 18 years or older with melanoma, breast cancer or head & neck cancer (including melanoma of head and neck area) and scheduled for a surgical SN procedure in the NKI-AvL without any contra-indication for Sonazoid contrast agent, such as an allergy to eggs or egg products. The primary objective is to assess the sensitivity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid). Secondary objectives are the specificity of CEUS for intra-operative SN localization, the time required to localize the SNs using CEUS and intraoperative usability of the CEUS-system. The primary endpoint is the sensitivity of the CEUS SN localization method. The conventional gamma probe will be used as ground truth comparison.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-operative Sonazoid injection | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonazoid | Drug | Intradermal injection of the ultrasound contrast agent Sonazoid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of the CEUS SN localization method | To assess the sensitivity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid). Could CEUS replace the conventional radioactive technetium method? | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of the CEUS SN localization method | Specificity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid) | 1 day |
| Time in minutes | Time required to localize the SNs using CEUS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marijn Hiep | Contact | +31205121751 | ma.hiep@nki.nl |
| Name | Affiliation | Role |
|---|---|---|
| Quirijn Tummers | The Netherlands Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netherlands Cancer Institute | Recruiting | Amsterdam | North Holland | 1066 CX | Netherlands |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D001943 | Breast Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C069727 | Sonazoid |
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| 1 day |
| System-usability score (SUS) and questionnaire for the surgeon. | Intraoperative usability of the CEUS-system. | 1 day |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001941 | Breast Diseases |