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Recruiting NCT07310758

Contrast-enhanced Ultrasound for Sentinel Node Detection

Phase II / Phase III Interventional Melanoma Breast Cancer Head & Neck Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sonazoid.
Who it may be relevant to
Registry conditions: Melanoma, Breast Cancer, Head & Neck Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Sonazoid
    Intradermal injection of the ultrasound contrast agent Sonazoid.

Primary outcome measures

  • Sensitivity of the CEUS SN localization method [Time frame: 1 day]
Secondary outcome measures (3)
  • Specificity of the CEUS SN localization method [Time frame: 1 day]
  • Time in minutes [Time frame: 1 day]
  • System-usability score (SUS) and questionnaire for the surgeon. [Time frame: 1 day]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Netherlands · 1 center
  • Netherlands Cancer Institute — Amsterdam

Identifiers

NCT: NCT07310758 · N24CUS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗