Contrast-enhanced Ultrasound for Sentinel Node Detection

NCT07310758 | Recruiting Phase 2

• 1 other identifier: N24CUS
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Breast Cancer; Head & Neck Cancer

Keywords

contrast-enhanced ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Specificity of the CEUS SN localization method

  1 day

• Time in minutes

  1 day

• System-usability score (SUS) and questionnaire for the surgeon.

  1 day

Study Arms (1)

Intra-operative Sonazoid injection

OTHER

Drug: Sonazoid

Interventions

Sonazoid DRUG

Intradermal injection of the ultrasound contrast agent Sonazoid.

Intra-operative Sonazoid injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• GE Healthcare: collaborator

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Melanoma; Breast Neoplasms; Head and Neck Neoplasms

Interventions

Sonazoid

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Breast Diseases

Study Officials

• Quirijn Tummers

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marijn Hiep

CONTACT

+31205121751; ma.hiep@nki.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): September 18, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

NL (1)