The use of handheld reflectance confocal microscopy in the surgical treamtent of lentigo maligna
- Conditions
- entigo malignaReflectance confocal microscopyDiagnostic accuracy
- Registration Number
- NL-OMON22810
- Lead Sponsor
- etherlands Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 61
Inclusion Criteria
i.Patients with histologically confirmed primary LM.
ii.Patients with histologically confirmed recurrent LM, defined by a clinical recurrence within 10mm from the previously treated area following (non-)surgical treatment ¡Ý 12 months ago.
Exclusion Criteria
i.Patients with histologically confirmed LMM according to the WHO 2011 criteria (WHO ICD-O-3 8742/3) as assessed by standard of care.
ii.Patients with incomplete excised LM or histological confirmed recurrence within < 12 months following (non-)surgical treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the diagnostic accuracy of HH-RCM in the presurgical margin delineation for primary and recurrent LM in the head and neck treated by conventional surgical excision.
- Secondary Outcome Measures
Name Time Method i.To evaluate the influence of HH-RCM on the surgical management of LM.<br /><br>ii.To determine the long-term effect of HH-RCM assisted margin delineation on treatment-failure, defined by histopathological confirmed recurrences and/or the development of invasive melanoma.<br /><br>i.To evaluate patient satisfaction with the use of HH-RCM in the management of LM.<br>