RecruitingPhase 2Phase 3NCT07310758

Contrast-enhanced Ultrasound for Sentinel Node Detection

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

Sponsor

The Netherlands Cancer Institute

Enrollment

91 participants

Start Date

Sep 18, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Melanoma Head & Neck Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria3

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