The use of handheld reflectance confocal microscopy in the surgical treamtent of lentigo maligna

Diagnostic accuracy of handheld reflectance confocal microscopy in the presurgical margin delineation of lentigo maligna in the head and neck

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22810

Enrollment

Registered

2018-06-05

Start date

2018-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lentigo maligna Reflectance confocal microscopy Diagnostic accuracy

Interventions

Presurgical margin delineation with handheld reflectance confocal microscopy

Eligibility

Inclusion criteria

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. iii. Lesion localization in the head and neck (i.e. supraclavicular/above the 7th cervical vertebrae). iv. Patients eligible for surgical excision. v. Anatomic localization of the lesion allows evaluation by HH-RCM. vi. Patient age ¡Ý 18 years and is willing and able to comply with the study requirements and give written informed consent.

Exclusion criteria

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. iii. Lesion localization outside the head and neck (i.e. infraclavicular/below the 7th cervical vertebrae). iv. Patients ineligible for surgical excision (e.g. cosmetic/functional ramifications, co-morbidity, patient refusal). v. Lesion localization is not accessible by HH-RCM.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
i. To evaluate the influence of HH-RCM on the surgical management of LM. 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. i. To evaluate patient satisfaction with the use of HH-RCM in the management of LM.	—

Contacts

Public ContactYannick Elshot

y.elshot@nki.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)