RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

Contrast-enhanced Ultrasound for Sentinel Node Detection

Contrast-enhanced Ultrasound for Sentinel Node Detection in Patients With Melanoma, Breast Cancer or Head & Neck Cancer

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Aged 18 years or older - Patient has been diagnosed with cancer in the skin (melanoma), breast or head \& neck (including melanoma of head and neck area) - In case of a melanoma: it should be located in the limbs or head and neck area - Scheduled for a surgical SN procedure at the NKI-AvL - Patient provides written willing to sign a consent form Who Should NOT Join This Trial: - Pregnancy - Any known clinically significant acute hypersensitivity reaction to the study medication, such as eggs or egg products - Other contra-indications for Sonazoid contrast agent, including arteriovenous cardiac or pulmonary shunt, serious coronary arterial disease and serious pulmonary disease Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Aged 18 years or older * Patient has been diagnosed with cancer in the skin (melanoma), breast or head \& neck (including melanoma of head and neck area) * In case of a melanoma: it should be located in the limbs or head and neck area * Scheduled for a surgical SN procedure at the NKI-AvL * Patient provides written informed consent Exclusion Criteria: * Pregnancy * Any known clinically significant acute hypersensitivity reaction to the study medication, such as eggs or egg products * Other contra-indications for Sonazoid contrast agent, including arteriovenous cardiac or pulmonary shunt, serious coronary arterial disease and serious pulmonary disease

Treatments Being Tested

DRUG

Sonazoid

Intradermal injection of the ultrasound contrast agent Sonazoid.

Locations (1)

Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands