Optimization of Photodynamic Therapy Through the Association With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Evaluation of the complete response rate after one month of treatment.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Photodynamic therapy (PDT) protocol
In this arm, lesions will be treated with the conventional PDT protocol for this type of lesion.
干预措施: Control Arm (Conventional Therapy) (Combination Product)
Sono-Photodynamic Therapy (SonoPDT) protocol
In this arm, lesions will be treated with a modified treatment protocol called SonoPDT protocol.
干预措施: Experimental arm (Combination Product)
结局指标
主要结局
Evaluation of the complete response rate after one month of treatment.
时间窗: One month after the treatment was applied to the patient.
Complete response will be defined as the absence of clinical and/or histopathological signs of the tumor after one month of treatment.
次要结局
- Evaluation of the complete response rate and recurrence-free survival rate after six months of treatment.(Six months after the treatment was applied to the patient.)
研究者
Ana Gabriela Salvio
Principal Investigator
University of Sao Paulo