Clinical Trial

Contrast-enhanced Ultrasound for Sentinel Node Detection

Recruiting Phase 2/3
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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.
Trial Details
NCT Number NCT07310758
Lead Sponsor The Netherlands Cancer Institute
Collaborators: GE Healthcare
Conditions Melanoma, Breast Cancer, Head & Neck Cancer
Enrollment 91 participants
Start Date 2025-09-18
Primary Completion 2026-09-18 (estimated)
Study Completion 2026-09-18 (estimated)
Updated on ClinicalTrials.gov 2025-12-30