NCT07310758RecruitingPhase 2/3
Contrast-enhanced Ultrasound for Sentinel Node Detection
Contrast-enhanced Ultrasound for Sentinel Node Detection in Patients With Melanoma, Breast Cancer or Head & Neck Cancer
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 91 (estimated)
- First submitted
- 16 Dec 2025
- Start date
- 18 Sept 2025
- Primary completion date
- 18 Sept 2026
- Lead sponsor
- The Netherlands Cancer Institute
- Diseases
- Head and neck cancer, Melanoma
- NCT number
- NCT07310758
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 91
- From 18 Sept 2025 to the primary completion date, 18 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Netherlands Cancer Institute Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.