Actively Recruiting
Contrast-enhanced Ultrasound for Sentinel Node Detection
Led by The Netherlands Cancer Institute · Updated on 2025-12-30
91
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
G
GE Healthcare
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Contrast-enhanced Ultrasound for Sentinel Node Detection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands, 1066 CX
Actively Recruiting
Research Team
M
Marijn Hiep
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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