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Contrast-enhanced Ultrasound for Sentinel Node Detection

NCT ID: NCT07310758

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-18

Study Completion Date

2026-09-18

Brief Summary

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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.

Detailed Description

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Conditions

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Melanoma Breast Cancer Head & Neck Cancer

Keywords

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contrast-enhanced ultrasound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intra-operative Sonazoid injection

Group Type OTHER

Sonazoid

Intervention Type DRUG

Intradermal injection of the ultrasound contrast agent Sonazoid.

Interventions

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Sonazoid

Intradermal injection of the ultrasound contrast agent Sonazoid.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Quirijn Tummers

Role: PRINCIPAL_INVESTIGATOR

The Netherlands Cancer Institute

Locations

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Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Marijn Hiep

Role: CONTACT

Phone: +31205121751

Email: [email protected]

Facility Contacts

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Marijn Hiep

Role: primary

Other Identifiers

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N24CUS

Identifier Type: -

Identifier Source: org_study_id