Condition: Melanoma · Breast Cancer · Head & Neck Cancer · Sponsor: The Netherlands Cancer Institute
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.
This description comes directly from the study's public registry record.
Marijn Hiep · +31205121751 · ma.hiep@nki.nl
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| Netherlands Cancer Institute | Amsterdam, North Holland, Netherlands | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07310758