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Clinical Trials in the Netherlands / NCT07310758
Recruiting Phase 2/3

Contrast-enhanced Ultrasound for Sentinel Node Detection

NCT07310758 · tracked via the Priya Life Science Netherlands tracker
Sponsor
The Netherlands Cancer Institute
Phase
Phase 2/3
Started
2025-09-18
Last updated
2025-12-30

Condition(s) studied

MelanomaBreast CancerHead & Neck Cancer

Investigational drug(s) / intervention(s)

Sonazoid →

Sonazoid: Intradermal injection of the ultrasound contrast agent Sonazoid.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Netherlands Cancer Institute Amsterdam North Holland Recruiting

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High Dose Chemotherapy in Oligo-metastatic Homologous Recombination Deficient Breast Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07310758 on ClinicalTrials.gov ↗ ← All trials in the Netherlands