Sentinel NOSE Study: Prospective Registration Study on the Sentinel Node Procedure for Bulky Squamous Cell Carcinoma of the Nasal Vestibule.
Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Nov 24, 2022
Trial Information
Current as of January 14, 2025
Completed
Keywords
ClinConnect Summary
Management of the neck in Wang cT1-T2N0 nasal vestibule carcinoma (NVC) has been an ongoing point of discussion. As the disease is rare publications are scarce and published regional recurrence rates vary widely between 0% up to 23%. In general, literature recommends adequate radiological neck staging followed by a watchful waiting policy, as overall regional recurrence rates are low (5-10%).
However, according to recent findings, a subset of patients with large or voluminous cT1-T2N0 NVC is deemed at high risk of nodal involvement (20-40% regional recurrence) but receive no elective treat...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Aged 18 years or older.
- • WHO performance score of 0, 1 or 2.
- • Newly diagnosed T1 or T2 squamous cell carcinoma of the nasal vestibule.
- • Tumor diameter ≥1.5 cm and/or tumor volume ≥1.5cm3
- • Clinically negative neck (N0).
- • Patients planned to undergo curative treatment.
- • Patient provided written informed consent
- Exclusion Criteria:
- • Prior allergic reaction to either indocyanide green, 99m-Technetium nanocolloid or human colloidal albumin.
- • Pregnancy.
- • Previous surgery or radiotherapy of the neck.
- • Concurrent secondary head-and-neck tumor.
- • Unable to provide informed consent
Trial Officials
Hans Kaanders, Prof., PhD, MD
Principal Investigator
Radboud University Medical Center
About Radboud University Medical Center
Radboud University Medical Center is a leading academic medical institution located in Nijmegen, the Netherlands, dedicated to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, Radboud UMC leverages its multidisciplinary expertise to conduct high-quality research that aims to improve patient outcomes and enhance medical knowledge. The center is committed to ethical standards and regulatory compliance, fostering collaboration among researchers, healthcare professionals, and patients to translate scientific discoveries into effective clinical applications. With a focus on personalized medicine and cutting-edge technologies, Radboud University Medical Center plays a pivotal role in shaping the future of healthcare through its rigorous clinical trial initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nijmegen, , Netherlands
Amsterdam, , Netherlands
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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