Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Lesion eradication
研究概览
简要总结
The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery).
详细描述
Surgery (conisation) of precancerous cervical lesions (dysplasia) increase the risk of preterm deliveries in young women. Photodynamic therapy (PDT) is a selective, tissue preserving method that may become a good treatment option for these patients.
This study will explore topical application of methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm). Different doses of MAL and HAL will be used with different application time, followed by illumination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Positive histology of CIN 1-3
排除标准
- •Patients with endocervical lesions
- •Patients with AGUS
- •Patients with invasive disease
- •Patients with porphyria
- •Patients sensitive to MAL and HAL
研究组 & 干预措施
MAL 3
干预措施: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) (Drug)
MAL 12
干预措施: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) (Drug)
HAL 10, 3
干预措施: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) (Drug)
HAL 10, 12
干预措施: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) (Drug)
HAL 40, 3
干预措施: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) (Drug)
HAL 40, 12
干预措施: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) (Drug)
结局指标
主要结局
Lesion eradication
时间窗: 6 months
次要结局
- Eradication of lesion and HPV(6 and 12 months)
- Safety assessment(6 months)