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

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

Plain Language Summary

Simplified for easier understanding

This study tests whether contrast-enhanced ultrasound (CEUS) — an imaging technique using a safe liquid injected into a vein to improve ultrasound images — can accurately identify sentinel lymph nodes (the first lymph nodes a cancer might spread to) in people with melanoma, breast cancer, or head and neck cancer before surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with melanoma (on the limbs or head/neck), breast cancer, or head and neck cancer - You are scheduled for a sentinel node procedure at the Netherlands Cancer Institute (NKI-AvL) **You may NOT be eligible if...** - You are pregnant - You have a known allergy to eggs or similar substances used in the contrast agent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSonazoid

Intradermal injection of the ultrasound contrast agent Sonazoid.


Locations(1)

Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands

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NCT07310758


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