Cutaneous melanoma
Conditions
Interventions
There is no investigational drug or device in this study.
All standard steps of the SLNB procedure (technetium injection, lymphoscintigraphy, surgery) remain the same.
The only study-related procedure
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Age =18 years.Patients with a primary cutaneous melanoma of the arm or leg.Scheduled for SLNB according to standard indications.Written informed consent.
Exclusion criteria
Exclusion criteria: Patients in whom technetium is not used for SLN detection.Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the number of sentinel lymph nodes detected by gamma probe compared with lymphoscintigraphy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Distance between skin markingsThe distance (in millimeters) between the preoperative lymphoscintigraphy mark and the UV mark obtained by gamma probe localization.Concordance of localization methodsAgreement between the different markings:scintigraphy markinggamma probe (UV) markingsurgical incision siteReported as overlap, alignment, or deviation.Sentinel lymph node locationAnatomical location of the SLN as identified during surgery (e.g., axilla, groin), documented from operative notes and photographs.Patient and tumor characteristicsExploratory assessment of factors potentially influencing SLN detection or localization, such as:agesexBMIprimary tumor location on the extremity (e.g., upper arm, lower leg)Ex vivo positivity of sentinel nodesWhether the surgically removed SLNs show technetium uptake on ex vivo measurement (yes/no). | — |
Countries
Netherlands
Contacts
Public ContactI Stekelenburg
St. Antonius Ziekenhuis
Outcome results
None listed