New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Treatment efficacy of Nd:YAG Laser 1064-nm for low risk basal cell carcinomas
研究概览
简要总结
The aim of this study is to show that the Nd:YAG laser could be a promising alternative treatment option in the management of low-risk basal cell carcinomas with similar high efficacy rates to surgery, and low recurrence rates evaluated over a time period of one year. Reflectance confocal microscopy, optical coherence tomography and clinical examination are used prior to confirm the clinical diagnosis of the basal cell carcinoma and for premargination of the tumor. The optical coherence tomography will also be used post treatment to confirm clearance of the basal cell carcinoma and to monitor treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with one or more basal cell carcinoma(s) on head, trunk or extremities
- •Diagnosed clinically, with a dermatoscope and through noninvasive imaging methods such as reflectance confocal microscopy and optical coherence tomography
- •H zone <6mm, M zone <10mm, L zone <20mm
- •Tumor thickness <2mm
- •Clearly visible margins
排除标准
- •Pregnancy
- •<18 years of age
- •Current or history of immunosuppression
- •Prior-treatment of the basal cell carcinoma/ recurrent basal cell carcinomas
- •History of radiation in the area of basal cell carcinoma appearance
结局指标
主要结局
Treatment efficacy of Nd:YAG Laser 1064-nm for low risk basal cell carcinomas
时间窗: 8 weeks after the treatment
Clearance rate of basal cell carcinomas after 1-3 Nd:YAG laser treatments evaluated by clinical inspectation, dermatosopy and optical coherence tomography.
Recurrence Rate after Nd:YAG Laser treatment
时间窗: 12 months
To assess the recurrence rate after a long-term follow-up of 6 and 12 months
次要结局
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(6 and 12 months after treatment)
- Cosmetic outcome after laser treatment(6 and 12 months after treatment)
研究者
Dr. Stephanie Geisler
Investigator, Resident in Dermatology
Medical University of Vienna