Contrast-enhanced Ultrasound for Sentinel Node Detection

Netherlands Cancer Institute (NKI)

Status and phase

Enrolling

Phase 3

Phase 2

Conditions

Breast Cancer

Melanoma

Head & Neck Cancer

Treatments

Drug: Sonazoid

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07310758

N24CUS

Details and patient eligibility

About

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.

Enrollment

91 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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