Contrast-enhanced Ultrasound for Sentinel Node Detection

Phase 3RecruitingNCT07310758

The Netherlands Cancer Institute91 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Melanoma Breast Cancer Head & Neck Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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?

Time frame: 1 day

Secondary Outcomes

Specificity of the CEUS SN localization method

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

Time frame: 1 day

Time in minutes

Time required to localize the SNs using CEUS.

Time frame: 1 day

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

Intraoperative usability of the CEUS-system.

Time frame: 1 day

Contrast-enhanced Ultrasound for Sentinel Node Detection

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts