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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50265

Enrollment

Registered

2023-05-09

Start date

2021-11-01

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

Melanoma skin cancer

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Scheduled for SLNB

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Concordance rate of SLNs identified by MSOT imaging and ICG versus the standard of care with Tc99m and lymphoscintigraphic imaging - Number of sentinel lymph nodes visualized with MSOT - Number of sentinel lymph nodes visualized with lymphoscintigraphy - Positive detection of ICG on the SLN specimen visualized with an ex vivo fluorescence imaging device	—

Countries

Netherlands

Outcome results