Melanoma, Breast Cancer, Head & Neck Cancer
Conditions
Keywords
contrast-enhanced ultrasound
Brief 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.
Interventions
DRUGSonazoid
Intradermal injection of the ultrasound contrast agent Sonazoid.
Sponsors
GE Healthcare
The Netherlands Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the CEUS SN localization method | 1 day | 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
| Measure | Time frame | Description |
|---|---|---|
| Specificity of the CEUS SN localization method | 1 day | Specificity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid) |
| Time in minutes | 1 day | Time required to localize the SNs using CEUS. |
| System-usability score (SUS) and questionnaire for the surgeon. | 1 day | Intraoperative usability of the CEUS-system. |
Countries
Netherlands
Contacts
Primary ContactMarijn Hiep
Outcome results
None listed