Sentinel lymph node detection in patients with stage Ib-III melanoma using MultiSpectral Optoacoustic Tomotraphy (MSOT) and IndoCyanine Green (ICG)

• Conditions: Melanoma; skin cancer; 10027476

• Registration Number: NL-OMON50265
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

Scheduled for SLNB

Exclusion Criteria

- Serious medical conditions which make inclusion in a clinical trial not
favourable as decided by the surgeon
- Apparent hyperthyroidism or autonomous thyroid adenoma of the thyroid gland
- Prior surgery or radiotherapy on involved lymph nodes / area
- Major surgery within 28 days before tracer administration
- Pregnant or nursing women, fertile women will need a negative pregnancy test
prior to inclusion
- History of iodine allergy or anaphylactic reactions to insect bites
- Skin type >IV following Fitzpatrick skin classification (MSOT less reliable)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Concordance rate of SLNs identified by MSOT imaging and ICG versus the standard<br /><br>of care with Tc99m and lymphoscintigraphic imaging<br /><br>- Number of sentinel lymph nodes visualized with MSOT<br /><br>- Number of sentinel lymph nodes visualized with lymphoscintigraphy<br /><br>- Positive detection of ICG on the SLN specimen visualized with an ex vivo<br /><br>fluorescence imaging device</p><br>

Secondary Outcome Measures

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