Whether preclinical studies either involve a cell or animal model, the distribution of light plays a determinant role in the reproducibility of results of photodynamic therapy (PDT) studies. Unfortunately, only few illumination devices dedicated to preclinical studies are available and are for the most, very expensive. Most research teams use home-made solutions that may not always be reproducible because of undefined light distribution, additive thermal emission, or unsuitable for shapes and volumes to illuminate. To address these issues, we developed illumination devices dedicated to our preclinical studies, which embed knitted light emitting fabrics (LEF) technology. LEF technology offers a homogeneous light distribution, without thermal emission and can be coupled with various light sources allowing investigation of several PDT modalities (irradiance, wavelength, illumination duration/mode). For in-vitro studies, we designed light plates, each allowing illumination of up to four 96-cells plates. For in-vivo studies, we designed mice boxes allowing three animals placement in prone position, equally surrounded by LEF and ensuring homogeneous extracorporeal illumination. Optical validation was performed and reproducibility of both preclinical systems were assessed. Both systems can deliver homogeneous light with an irradiance that can reach several mW/cm2, with varying durations and wavelengths. First results of preclinical studies demonstrate a high reproducibility, with an easy setup, and a great adaptability of illumination modalities with these devices based on light emitting fabrics.
Primary Extramammary Paget’s disease (EMPD) is a rare cancer that mainly affects the genital region including vulvar and perianal areas. Without treatment, vulvar EMPD progresses and presents always more erythematous and pruritic plaques, which may become ulcerated and erosive. To control disease progression and symptoms usually experienced by patients, surgical excision is the mainstay of treatment. Unfortunately, even after large surgical excision with intra-operative margin control, recurrences are common [1]. For recurrent patients which undergo multiple resections, severe functional and sexual alterations are described. Only few data are available on the efficacy of alternative conservative treatments, such as laser ablation, radiotherapy, topical chemotherapy and photodynamic therapy (PDT) [2]. To date, none of them can be considered as a solid alternative to surgical excision yet [3]. Nonetheless, multiple clinical cases suggest that PDT could provide the opportunity to treat subclinical lesions, and give some relief on patient’s symptoms of the disease [4-6]. Unfortunately, the benefits of using photodynamic therapy for vulvar EMPD remains a challenge to demonstrate, because of the inhomogeneous illumination of vulvar and perianal areas, and the extreme pain that patients usually experienced during the illumination procedure that may lead to premature end of treatment [7, 8]. Resulting from the knowledge of previous works on actinic keratosis of the scalp treatment with PDT, light emitting fabrics (LEF) technology could address both of the hereinbefore described issues [9-12]. A new medical device based on LEF named PAGETEX dedicated to illumination of vulvar and perianal areas has been developed. The device delivers a homogeneous red light (635 nm) with a low irradiance during 2h30, for a total fluence of 12 J/cm2. The PAGETEX device is being assessed in a clinical study (NCT03713203) which aims to establish PAGETEX- PDT efficacy and tolerability.
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