Contrast-enhanced Ultrasound for Sentinel Node Detection

Sponsor
The Netherlands Cancer Institute
Study ID
NCT07310758
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sonazoid — DRUG
    Intradermal injection of the ultrasound contrast agent Sonazoid.

Study Details

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.

Key Dates

First listed
Dec 30, 2025
Start date
Sep 18, 2025
Status verified
Dec 2025
Primary completion
Sep 18, 2026
Completion
Sep 18, 2026

Study Design

Enrollment
91 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Intra-operative Sonazoid injection

Primary Outcome Measure

Sensitivity of the CEUS SN localization method [ Time Frame: 1 day ]

Central Contacts

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