Photodynamic therapy (PDT) is a therapeutical modality which offers a minimally invasive alternative for high-grade cervical intraepithelial neoplasia (CIN) treatment. This prospective randomized controlled clinical trial aims to compare two PDT protocols for the treatment of histopathologically similar high-grade CIN. The patients were followed 60 days and two years after the treatment by cytology, hybrid capture and pathology analysis after the Excision of Transformation Zone (ETZ). Preliminary results are indicating, after two years follow-up, that combining ecto and endocervix treatment leads to better cure rates of high-grade CIN.
It is estimated that up to 75% of the sexually active population is infected with this human papillomavirus virus (HPV). Condylomas acuminate are benign lesions caused by this virus. This study aims to compare photodynamic therapy (PDT) and administration of 70% trichloroacetic acid (TAA) in the condylomas. Each patient is treated weekly until total removal of the lesions, with one of treatment options. In the patients treated with PDT, a Brazilian 20% methyl aminulevulinate cream were applied in the region and incubated by 3 hours and the lesions were illuminated with the CERCa®. This Brazilian system is composed of LEDs emitting at 630 nm which was initially designed for the treatment of cervical intraepithelial neoplasia (CIN) and this study showed the need to develop new devices for illumination of the anus-genital region. During the illumination, a total dose of 150 J/cm2 is delivered over 21 minutes. 22 patients have participated of this clinical study, totaling 15 patients treated with TAA and 8 with PDT, with a complete treatment for 33% using TAA and 75% for PDT. Besides the results of complete response, it is important to highlight that 2 patients showed recurrence for TAA and 4 patients discontinued the treatment with TAA, while, for PDT, there were no cases both recurrence and withdrawal. Therefore, besides the preliminary results obtained with this project show that PDT has been more effective than TAA, it was possible to plan and develop new equipment to ensure greater range of light.
Cervical cancer is the fourth most frequent cancer in women worldwide. For Brazil, there are estimated 16,370 new cases of cervical cancer for each year of the biennium of 2018-2019, with an estimated risk of 15.43 cases per 100,000 women, occupying the third position [1]. Persistent infection with Human papillomavirus (HPV) has been identified as the major cause of the Cervical Intraepithelial Neoplasia (CIN), a precursor of cervical cancer. The classification of CIN is based on the cellular features to discriminate dysplasia levels, being CIN 1 as mild dysplasia and CIN 2/3 as moderate or severe dysplasia [2]. Cervical cancer can be prevented with a early CIN diagnosis and treatment [3].
Cervical intraneoplasia (CIN), during its progression, shows an increased cell atypia and affects thicker epithelial structure. Photodynamic therapy (PDT) may constitute an attractive minimally invasive treatment technique. CIN mostly occurs at the squamous-columnar junction (SCJ) of the cervix, resulting in a challenge to achieve the aimed PDT uniform photosensitizer distribution and irradiation. The development of the clinical protocol and of the customized optical treatment probe is essential for an improved PDT response for CIN 1,2 and 3. Results of the developed instrumentation in an ongoing clinical study will be discussed.
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