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Clinical Trials/2024-515259-40-00
2024-515259-40-00RecruitingPhase 3

Contrast-enhanced ultrasound for sentinel node detection in patients with melanoma, breast cancer or head & neck cancer (N24CUS)

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting1 site in 1 country91 target enrollmentStarted: December 9, 2024Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
91
Locations
1
Primary Endpoint
sensitivity and specificity of the CEUS SN localization method
Study OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To assess the sensitivity and specificity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid).

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

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

  • •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 and specificity of the CEUS SN localization method

sensitivity and specificity of the CEUS SN localization method

Secondary Outcomes

  • time required to localize the SNs using CEUS in minutes
  • usability of the CEUS system using a system-usability-score (SUS)
  • sensitivity and specificity of using CEUS to predict if SNs are malignant

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Dr. Q.R.J.G. Tummers

Scientific

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Study Sites (1)

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