Contrast-enhanced Ultrasound for Sentinel Node Detection
Recruiting now · Phase 2/Phase 3
Conditions studied: Melanoma, Breast Cancer, Head & Neck Cancer
In brief
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.
Key facts
- Study ID
- NCT07310758
- Run by
- The Netherlands Cancer Institute
- People needed
- 91
- Starts
- 2025-09-18
- Expected to finish
- 2026-09-18
- Last updated by the study team
- 2025-12-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Netherlands Cancer Institute — Amsterdam, North Holland, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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