Evaluation of Protoporphyrin Formation in Non-Melanoma Skin Cancers After Topical Application of 5-Aminolevulinic Acid: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 18
- 主要终点
- Maximum depth of protoporphyrin IX (PpIX) fluorescence within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration
研究概览
简要总结
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with nonmelanoma skin cancer that has been treated with topical aminolevulinic acid may help doctors predict how patients will respond to photodynamic therapy.
PURPOSE: This clinical trial is studying topical aminolevulinic acid in patients with nonmelanoma skin cancer.
详细描述
OBJECTIVES:
- To evaluate the distribution and depth of protoporphyrin IX (PpIX) within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration.
- To obtain in vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods.
- To correlate the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors.
- To establish a skin cancer tissue bank.
OUTLINE: Topical aminolevulinic acid (ALA) is applied to the center of the tumor surface. Patients then undergo punch tumor biopsy of the area where the ALA is applied followed by surgery to remove the tumor. Tissue samples are assessed for protoporphyrin (PpIX) levels by fluorescence confocal microscopy and hyperspectral imaging. Excess tumor tissue may be stored in a skin cancer tissue bank. Surface measurements (from a total of 5 surface sites) of PpIX fluorescence are taken at baseline and at 2 hours after ALA application using an optical fiber-based hand-held dosimeter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Must have at least 1 biopsy-proven nonmelanoma skin cancer with a minimum diameter of 4 mm
- •No tumors located on the eyelids, distal nose, cartilaginous portions of the ears, or lips
- •PATIENT CHARACTERISTICS:
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No known hypersensitivity to aminolevulinic acid or any component of this medication
- •PRIOR CONCURRENT THERAPY:
- •Concurrent immunosuppressive or chemotherapeutic medications allowed
- •Concurrent corticosteroids (taken by mouth or large doses taken with an inhaler) allowed
- •Concurrent systemic retinoids (e.g., isotretinoin, acitretin, bexarotene, alitretinoin) or vitamin A allowed
- •Other concurrent medications that may affect epidermal growth and differentiation (e.g., anti-EGFR monoclonal antibodies) allowed
- •No concurrent participation in another clinical trial
- •No concurrent topical treatment for the target tumor or for other nonmelanoma skin cancers
- •No concurrent medical therapy or radiotherapy for other cancers
排除标准
- 未提供
结局指标
主要结局
Maximum depth of protoporphyrin IX (PpIX) fluorescence within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration
时间窗: Day 1
次要结局
- In vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods(Day 1)
- Correlation of the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors(Day 1)
- Establishment of a skin cancer tissue bank(Day 1)