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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
ID07310758

Using Contrast-enhanced Ultrasound with Sonazoid to Detect Sentinel Nodes in Patients with Melanoma, Breast Cancer, or Head and Neck Cancer

Led by The Netherlands Cancer Institute · Updated on 2025-12-30

91

Participants Needed

1

Research Sites

N/A

Total Duration

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

Research Team

M

Marijn Hiep

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