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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49091

Enrollment

Registered

2020-10-13

Start date

2021-01-12

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hoofd hals maligniteiten anterior nose cancer nasal vestibule carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study will be successful identification of sentinel nodes on lymphoscintigraphy and SPECT imaging. The procedure will be considered feasible when one or more sentinel nodes can be identified and localized in at least 7 out of the 10 patients.	—

Secondary

Measure	Time frame
The secondary outcomes will be: yield of at least one lymph node after biopsy, incidence of surgical complications and pain score during and after peritumoral tracer injection and tracer.	—

Countries

Netherlands

Outcome results