NCT07310758

Contrast-enhanced Ultrasound for Sentinel Node Detection

Contrast-enhanced Ultrasound for Sentinel Node Detection in Patients With Melanoma, Breast Cancer or Head & Neck Cancer

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 91 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma
• Breast Cancer
• Head & Neck Cancer

Interventions

Type	Name	Description
DRUG	Sonazoid	Intradermal injection of the ultrasound contrast agent Sonazoid.

Timeline

• Start date: 2025-09-18
• Primary completion: 2026-09-18
• Completion: 2026-09-18
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

1 site across 1 country: Netherlands