Clinical trial · Interventional
Contrast-enhanced Ultrasound for Sentinel Node Detection
Contrast-enhanced Ultrasound for Sentinel Node Detection in Patients With Melanoma, Breast Cancer or Head & Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Head & Neck Cancer | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sonazoid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Intra-operative Sonazoid injection
- interventionNames
- Drug: Sonazoid
Primary outcomes (1)
- measure
- Sensitivity of the CEUS SN localization method
- timeFrame
- 1 day
- description
- To assess the sensitivity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid). Could CEUS replace the conventional radioactive technetium method?
Secondary outcomes (3)
- measure
- Specificity of the CEUS SN localization method
- timeFrame
- 1 day
- description
- Specificity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available