Actively Recruiting
Contrast-enhanced Ultrasound for Sentinel Node Detection in Patients With Melanoma, Breast Cancer or Head & Neck Cancer
Led by The Netherlands Cancer Institute · Updated on 2025-12-30
91
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the use of contrast-enhanced ultrasound (CEUS) with the Sonazoid contrast agent to detect sentinel lymph nodes during surgery in patients aged 18 years or older diagnosed with melanoma, breast cancer, or head and neck cancer (including melanoma in these areas). This study compares the sensitivity of CEUS for locating sentinel nodes against the current gold standard method using 99mTc nanocolloid and a gamma probe. The goal is to determine if CEUS can accurately and efficiently identify sentinel nodes during surgery. Participants will receive an intradermal injection of the Sonazoid ultrasound contrast agent during their scheduled surgical sentinel node procedure. This is a single-day interventional study conducted at one center, focused on assessing intra-operative sentinel node localization. The study also evaluates the specificity of CEUS, the time needed to locate sentinel nodes using CEUS, and the ease of using the CEUS system for surgeons. During the procedure, researchers will monitor how well CEUS identifies sentinel nodes compared to the conventional gamma probe method. They will measure outcomes including sensitivity, specificity, time required, and surgeon usability scores from questionnaires. Participants are involved only for the day of their surgery, with no ongoing treatment or long-term follow-up specified. Safety monitoring includes checking for any allergic reactions or contraindications to Sonazoid.
CONDITIONS
Brief Title
Contrast-enhanced Ultrasound for Sentinel Node Detection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosed with melanoma, breast cancer, or head and neck cancer (including melanoma in the head and neck area)
- For melanoma patients, the tumor should be located in the limbs or head and neck area
- Scheduled for a surgical sentinel node procedure at the NKI-AvL
- Able and willing to provide written informed consent
You will not qualify if you...
- Pregnant
- Known significant acute hypersensitivity to the study medication, such as allergy to eggs or egg products
- Contraindications for Sonazoid contrast agent, including arteriovenous cardiac or pulmonary shunt, serious coronary artery disease, or serious pulmonary disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive an intradermal injection of the ultrasound contrast agent Sonazoid during their surgical sentinel node procedure, followed by immediate post-operative care.
1 intra-operative visit and post-operative assessment
Trial Site Locations
Total: 1 location
1
Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands, 1066 CX
Actively Recruiting
Research Team
M
Marijn Hiep
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here