Lentigo Maligna Clinical Trial
Official title:
Photodynamic Therapy for Melanoma Precursor Lesion Lentigo Maligna Using 5-aminolevulinic Acid Nanoemulsion (BF-200 ALA) as a Light Sensitizing Cream
This study investigates the efficacy of photodynamic therapy (PDT) in the treatment of lentigo maligna (LM). Hyperspectral imaging system (HIS) will be used to determine the margins of LM and to rule out possible invasion. Participants will receive photodynamic therapy three times consecutively with intervals of two weeks using 5-aminolevulinic acid nanoemulsion (BF-200 ALA, Ameluz®) as a light sensitizing cream. Four weeks after last photodynamic therapy the lentigo maligna lesion will be excised surgically from the skin. Result of the treatment is assessed with histopathological examination and immunohistochemical staining of removed tissue specimen.
Lentigo maligna (LM) is an in-situ form of melanoma which occurs on sun-exposed skin.
Untreated LM can progress into invasive lentigo maligna melanoma (LMM). The incidence of
LM/LMM is constantly increasing as the population grows older and lifelong sun-exposure is on
the rise. Clinically it is difficult both to determine the borderline of LM as well as to
differentiate LMM from LM. A novel imaging method hyperspectral imaging system (HIS) can be
used for delineating margins of LM and for spotting invasion inside LM lesion. The gold
standard treatment for LM is surgical excision with adequate (≥5 mm) margins. Due to large
size of LM lesions and typical location on face or neck the surgical treatment is challenging
and can cause aesthetic and functional deficit for the patient. Furthermore, LM patients tend
to be elderly who may have anesthetic contraindications. Other treatment modalities for LM
have been studied but none of them still has proved to be efficient enough. Recently,
photodynamic treatment (PDT) has been suggested as a promising novel treatment method for LM.
In this prospective pilot study we investigate whether the photodynamic therapy (PDT) is
effective for treatment of lentigo maligna. 10-15 patients with a histologically confirmed
lentigo maligna are included in the trial. The study course is as follows: During the first
visit in the clinic, the suspected LM lesion is examined clinically under Wood's lamp and
imaged with a HIS camera. Elicited margins from both methods are marked on a transparent
sheet and the treatment area is photographed. A biopsy is taken from the darkest-colored part
of LM to confirm diagnosis and to rule out invasion. Next, the patients receive PDT treatment
three times with 2 weeks' intervals. Before applying the Ameluz® light sensitizer gel the
skin of treatment area is prepared with fractional ablative CO2-laser to enhance absorption.
After light sensitizer absorption the LM lesion is illuminated with artificial red light
(Aktilite CL128 lamp) using a light dose of 90 J/cm2. Finally 4 weeks after the last PDT
treatment LM is excised surgically using 5 mm margins. The efficacy of PDT is assessed after
surgical excision with histopathological examination and immunohistochemical staining (MART,
Mel-5 and MITF stains). The final result of the treatment is controlled 6 months after the
surgical excision.
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