Contrast-enhanced ultrasound to locate sentinel lymph nodes during cancer surgery
Official title: Contrast-enhanced Ultrasound for Sentinel Node Detection in Patients With Melanoma, Breast Cancer or Head & Neck Cancer
Run by The Netherlands Cancer Institute · NCT07310758 · Data updated 2026-11-12
This will test whether a contrast-enhanced ultrasound scan using Sonazoid can find sentinel lymph nodes during surgery in adults with melanoma, breast cancer, or head and neck cancer.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 91 (estimated) |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Status | Recruiting |
| Started | September 18, 2025 |
| Main results expected | September 18, 2026 |
| Study ends | September 18, 2026 |
| Registry record updated | December 30, 2025 |
| Trial ID | NCT07310758 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with diagnosed melanoma, breast cancer, or head and neck cancer who are scheduled for a sentinel node procedure at the Netherlands Cancer Institute and have no contraindication to Sonazoid may be eligible.
✕Probably not a fit
Patients who are pregnant, have known hypersensitivity to Sonazoid components (such as eggs), significant cardiac or pulmonary shunts, or who are not having a sentinel node procedure are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center, non-inferiority interventional study comparing contrast-enhanced ultrasound (CEUS) with Sonazoid to the conventional 99mTc nanocolloid/gamma probe for intra-operative sentinel node (SN) localization. Adults scheduled for a surgical SN procedure at the Netherlands Cancer Institute will undergo CEUS on the day of surgery and results will be compared to the gamma probe as the reference standard. The primary endpoint is the sensitivity of CEUS for SN localization, with secondary endpoints including specificity, time to localize SNs, and intraoperative usability of the CEUS system. Subjects with contraindications to Sonazoid (for example egg allergy, certain cardiac or pulmonary shunts) or pregnancy are excluded.
Why it matters
Potential benefit: If successful, CEUS could provide a faster, non-radioactive way to find sentinel lymph nodes during surgery and simplify localization procedures.
How similar studies have gone: Prior small studies and pilot work using contrast-enhanced ultrasound for sentinel node detection have shown promising results but the approach is not yet established as equivalent to radiocolloid mapping.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands Recruiting
Study contacts
- Principal investigator: Quirijn Tummers — The Netherlands Cancer Institute
- Study coordinator: Marijn Hiep
- Email: ma.hiep@nki.nl
- Phone: +31205121751
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.