Evaluation of near-infrared fluorescence (NIRF) imaging for sentinel lymph node (SLN) detection in squamous cell carcinoma of the vulva: a feasibility study

• Conditions: sentinel lymph node; vulvar carcinoma; 10038597; 10029903

• Registration Number: NL-OMON33082
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

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

Inclusion Criteria

female > 21 yrs of age with biopsy proven squamous cell carcinoma of the vulva who are eligible for a sentinel node procedure

Exclusion Criteria

Pregnant women, significant renal (creatinine > 110 ug/l), cardiac, or pulmonary disease (ASA III-IV), History of iodine allergy or anaphylactic reactions to insect bites or medication, presence or history of hyperthyroidism.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>the number and localisation of sentinel lymph node(s) detected with the camera<br /><br>and ICG, compared to the detection with radiocolloid and patent blue</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a</p><br>