NCT07310758 Contrast-enhanced Ultrasound for Sentinel Node Detection
| NCT ID | NCT07310758 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | The Netherlands Cancer Institute |
| Condition | Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 91 participants |
| Start Date | 2025-09-18 |
| Primary Completion | 2026-09-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 91 participants in total. It began in 2025-09-18 with a primary completion date of 2026-09-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Quirijn Tummers
PRINCIPAL INVESTIGATOR
The Netherlands Cancer Institute
Frequently Asked Questions
Who can join the NCT07310758 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07310758 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07310758 currently recruiting?
Yes, NCT07310758 is actively recruiting participants. Contact the research team at ma.hiep@nki.nl for enrollment information.
Where is the NCT07310758 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT07310758 clinical trial?
NCT07310758 is sponsored by The Netherlands Cancer Institute. The principal investigator is Quirijn Tummers at The Netherlands Cancer Institute. The trial plans to enroll 91 participants.
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