Detection of sentinel lymph nodes in laryngeal cancer by injection of 99mTc-nanocolloid via flexible laryngoscopy as a new technique

• Conditions: Laryngeal cancer; Laryngeal carcinoma; 10038666

• Registration Number: NL-OMON51411
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

- proven carcinoma of the larynx
- > 18 yrs of age
- undergo a TL with planned neck dissection.
- informed consent

Exclusion Criteria

- history of 99mTc-nanocolloid or human albumin allergy or anaphylactic
reactions
- (potential) pregnancy or lactating women

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Feasibility of injecting 99mTc-nanocolloid via a routinely used flexible<br /><br>laryngoscope with a working channel will be evaluated by pre-operative imaging<br /><br>and measuring 99mTc-nanocolloid activity at the injection site and in regional<br /><br>lymph nodes. Subsequently diagnostic accuracy of the used technique<br /><br>(sensitivity, specificity, positive and negative predictive value and<br /><br>diagnostic accuracy) for detection of SLN will be calculated by using<br /><br>histopathological results as gold standard.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Preoperative located SLN via gamma camera imaging will be compared to<br /><br>intraoperative located SLN using a gamma probe. </p><br>