Cutaneous Absorption and Intralesional Penetration of Topical Amino-Levulinic Acid in Basal Cell Carcinoma and Squamous Cell Carcinoma as Measured by In Situ Fluorescence and Intensified Video Fluorescence Microscopy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Depth of penetration of aminolevulinic acid as measured by the accumulation of protoporphyrin IX
研究概览
简要总结
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid cream may be effective in treating patients with skin cancer.
PURPOSE: This randomized phase II trial is studying how well photodynamic therapy works in treating patients with skin cancer.
详细描述
OBJECTIVES:
- Characterize the penetration of topically applied aminolevulinic acid (ALA) into the lesions of patients with primary basal cell and squamous cell carcinomas.
- Quantitate the depth of fluorescence achievable with varying application periods of ALA in these patients.
- Compare the results of tissue fluorescence with surface fluorescence measurements in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to lesion type (superficial basal cell carcinoma (BCC) vs nodular BCC vs squamous cell carcinoma). Patients within each group are randomized to receive one of two application times: 4-5 or 20-24 hours in duration.
Aminolevulinic acid is topically applied either in a cream mixture or an alcohol base and an occlusive dressing placed over the lesion. After the randomized treatment duration has expired, the dressing is removed and quantitative protoporphyrin IX fluorescence measurements from the tumor and surrounding skin are mapped using a fluorometer. Routine surgical excision is then performed on the carcinoma.
Patients return after one to two weeks for a follow-up examination and suture removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically proven basal cell carcinoma or squamous cell carcinoma
- •Candidate for complete surgical excision
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •No inflammation or infection of treated area
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Biopsy at least 2 weeks prior to surgery
排除标准
- 未提供
结局指标
主要结局
Depth of penetration of aminolevulinic acid as measured by the accumulation of protoporphyrin IX
次要结局
未报告次要终点