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Contrast-enhanced Ultrasound for Sentinel Node Detection

NCT07310758 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-12-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Sonazoid

Intradermal injection of the ultrasound contrast agent Sonazoid.

Sponsors & Collaborators

  • GE Healthcare

    collaborator INDUSTRY

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Quirijn Tummers · The Netherlands Cancer Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-18
Primary Completion
2026-09-18
Completion
2026-09-18

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07310758 on ClinicalTrials.gov