Sentinel node localization in larynx and pharynx cancers after flexible endoscopy-guided tracer injection: a feasibilty study

Phase 2

Completed

• Conditions: larynx- pharynx cancer; throat cancer; 10027656

• Registration Number: NL-OMON48222
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

-male or female aged > 18 years
-mucosal tumor of the oropharynx, hypopharynx or larynx
-patients planned to undergo biopsy via flexible endoscopy
-patients planned to undergo curative radiotherapy with or without concurrent chemotherapy
-patient provided written informed consent

Exclusion Criteria

-patients who underwent previous surgery or radiotherapy to the neck
-patients with airway obstruction causing stridor
-prior allergic reaction to Tc-99m-nanocolloid
-pregnancy
-unable to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A SPECT image of sufficient quality for localization of the sentinel node(s).<br /><br>This is a qualitative endpoint and is assessed by consensus between a nuclear<br /><br>medicine physician (A. Arens), head and neck surgeons (J. Honings, R. Takes, W.<br /><br>Weijs) and a radiation oncologist (J. Kaanders).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Is it feasible to administer at least 2 injections during the same procedure?<br /><br>2. Can sentinel nodes identified by SPECT be recognized on routine CT or MRI?</p><br>