Contrast-enhanced Ultrasound for Sentinel Node Detection

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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma; Breast Cancer; Head & Neck Cancer
• Intervention / Treatment: Drug: Sonazoid

• Study Type: Interventional
• Enrollment (Estimated): 91
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Marijn Hiep; Phone Number: +31205121751; Email: ma.hiep@nki.nl

Study Locations

• Netherlands
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1066 CX
      • Recruiting
      • Netherlands Cancer Institute
      • Contact: Marijn Hiep; Phone Number: +31205121751; Email: ma.hiep@nki.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intra-operative Sonazoid injection	Drug: Sonazoid; Intradermal injection of the ultrasound contrast agent Sonazoid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the CEUS SN localization method	To assess the sensitivity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid). Could CEUS replace the conventional radioactive technetium method?	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity of the CEUS SN localization method	Specificity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid)	1 day
Time in minutes	Time required to localize the SNs using CEUS.	1 day
System-usability score (SUS) and questionnaire for the surgeon.	Intraoperative usability of the CEUS-system.	1 day

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Collaborators: GE Healthcare
• Investigators: Principal Investigator: Quirijn Tummers, The Netherlands Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2025
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): September 18, 2026

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: contrast-enhanced ultrasound
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Breast Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Breast Neoplasms; Head and Neck Neoplasms; Melanoma; Sonazoid
• Other Study ID Numbers: N24CUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No