Photodynamic Therapy Associated With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma

Официальное название

Optimization of Photodynamic Therapy Through the Association With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma

Обзор

Evaluation of a therapeutic protocol based on the combination of photodynamic therapy and sonodynamic therapy, referred to as sonophotodynamic therapy. Since this new protocol is applied in a single day, it is called the single-visit Sono-PDT protocol. This protocol will be used for the treatment of nodular basal cell carcinoma lesions.

Подробное описание

In the proposed treatment protocol, all the procedures of traditional PDT protocol will be maintained, with the addition of a dose of low-intensity therapeutic ultrasound immediately after the application of red light. Ultrasound, due to its greater ability to penetrate the skin, can help reach deeper tumor cells and thus improve treatment outcomes.

Вмешательства

• Комбинированный продукт Control Arm (Conventional Therapy)
  PDT protocol: This intervention consists of two therapeutic sessions performed on the same day. The first session involves the application of MAL (methyl aminolevulinate) cream to the skin tumor, followed by an incubation period of 3 hours. After this time, the lesion is illuminated for 20 minutes at an irradiance of 125 mW/cm² using the LINCE device. Following the illumination procedure, the second session begins with a new application of MAL cream and an additional 1.5 hours of incubation. Aft
• Комбинированный продукт Experimental arm
  SonoPDT protocol: This intervention consists of two therapeutic sessions performed on the same day. The first session involves the application of MAL (methyl aminolevulinate) cream to the skin tumor, followed by an incubation period of 3 hours. After this time, the lesion is illuminated for 20 minutes at an irradiance of 125 mW/cm² using the LINCE device. Immediately after illumination, the lesion will be irradiated with ultrasound (frequency: 1MHz, mode: pulsed, ultrasound intensity: 1.5 W/cm2,

Первичные конечные точки

• Evaluation of the complete response rate after one month of treatment. [Срок оценки: One month after the treatment was applied to the patient.]

Вторичные конечные точки (1)

• Evaluation of the complete response rate and recurrence-free survival rate after six months of treatment. [Срок оценки: Six months after the treatment was applied to the patient.]

Критерии участия

Критерии включения

• Adults of both sexes, aged 18 years and older.
• Histologically confirmed nodular basal cell carcinoma with lesion diameter ≤1.0 cm.
• Participants with multiple lesions may be included, provided that each lesion meets all inclusion criteria.

Критерии исключения

• Nodular basal cell carcinoma lesions >1.0 cm in diameter.
• Known hypersensitivity or allergy to methyl aminolevulinate (MAL) or any excipients of the study medication.
• Histological subtypes of infiltrative basal cell carcinoma, including micronodular, infiltrative, sclerodermiform (morpheaform), plano-cicatricial, or terebrant subtypes.
• Porphyria or other disorders of porphyrin metabolism.
• Pregnant or breastfeeding women.
• Women of childbearing potential not using an acceptable method of contraception.
• Presence of photosensitive diseases, including lupus erythematosus.
• Any condition that, in the investigator's opinion, would interfere with study participation or safety.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Hospital Amaral Carvalho — Jaú

Публикации

• Ayala ETP, Carvalho ISE, Antunes CA, Mahmood A, Requena MB, Alves F, Pires L, Yakovlev V, Bagnato VS, Pratavieira S. Comparative analysis of ALA mediated sonodynamic therapy considering tumor size, light combination and ultrasound delivery in murine cutaneous melanoma. Sci Rep. 2025 Aug 22;15(1):30859. doi: 10.1038/s41598-025-16366-x. PMID 40846765
• Salvio AG, Veneziano DB, Moriyama LT, Inada NM, Grecco C, Kurachi C, Bagnato VS. A new photodynamic therapy protocol for nodular basal cell carcinoma treatment: Effectiveness and long-term follow-up. Photodiagnosis Photodyn Ther. 2022 Mar;37:102668. doi: 10.1016/j.pdpdt.2021.102668. Epub 2021 Dec 1. PMID 34863948

Идентификаторы

NCT: NCT07381972 · 7.810.244 · U1111-1330-4954

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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