Ultrasound with contrast agent to find sentinel nodes in some cancers
Tests contrast ultrasound for finding sentinel nodes in adults with skin, breast or head cancer.
Plain-language title generated from the registry record
Registry title: Contrast-enhanced Ultrasound for Sentinel Node Detection
Key facts
- Where
- Amsterdam, NetherlandsSee the site
- Phase
- Phase 2/3
Where in Netherlands
- Netherlands Cancer InstituteAmsterdam, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Netherlands Cancer Institute
- Trial code
- NCT07310758
- Record updated
- 30 December 2025
- Original description
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.Read full original descriptionShow less
Contrast-enhanced Ultrasound for Sentinel Node Detection in Patients With Melanoma, Breast Cancer or Head & Neck Cancer
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.
Inclusion: 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: 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; Pregnancy.