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NCT Number: NCT07310758

Contrast-enhanced Ultrasound for Sentinel Node Detection

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.

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Key information

Conditions

Melanoma Breast Cancer Breast Diseases Breast Neoplasms Head & Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

Location status: Recruiting

Location contact

Marijn Hiep

CONTACT

[email protected]

+31205121751

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sonazoid

Drug

Intradermal injection of the ultrasound contrast agent Sonazoid.

Primary outcomes

  1. Sensitivity of the CEUS SN localization method

    Time frame: 1 day

    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?

Secondary outcomes

  1. Specificity of the CEUS SN localization method

    Time frame: 1 day

    Specificity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid)

  2. Time in minutes

    Time frame: 1 day

    Time required to localize the SNs using CEUS.

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

    Time frame: 1 day

    Intraoperative usability of the CEUS-system.

Study contacts

Contact information is provided by the study sponsor or research team.

Marijn Hiep

CONTACT

[email protected]

+31205121751

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Collaborators

  • GE Healthcare

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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