Prospective registration study on the sentinel node procedure for bulky squamous cell carcinoma of the nasal vestibule

Phase 2

Completed

• Conditions: hoofd hals maligniteiten; anterior nose cancer; nasal vestibule carcinoma; 10040900

• Registration Number: NL-OMON49091
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-11-20
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

* 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.

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study will be successful identification of<br /><br>sentinel nodes on lymphoscintigraphy and SPECT imaging. The procedure will be<br /><br>considered feasible when one or more sentinel nodes can be identified and<br /><br>localized in at least 7 out of the 10 patients. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes will be: yield of at least one lymph node after biopsy,<br /><br>incidence of surgical complications and pain score during and after peritumoral<br /><br>tracer injection and tracer.</p><br>