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Contrast-enhanced Ultrasound for Sentinel Node Detection

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllThe Netherlands Cancer Institute
NCT07310758 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Sonazoid
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Where

1 site
Netherlands Cancer Institute
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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