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Search / Trial NCT05637307

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 February 05, 2025

Completed

Keywords

Nasal Vestibule, Sentinel Node, Nodal Metastases

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.

Locations

Nijmegen, , Netherlands

Amsterdam, , Netherlands

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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