Tissue Oxygen Imager
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Detecting cutaneous malignant lesions using a non-invasive technique
研究概览
简要总结
The primary objective of this study is the evaluation of the efficacy of the tissue oxygen imager based on PpIX DF in differentiating benign skin growth from non-melanoma skin cancer (NMSC).
详细描述
The present study is an open-label, non-randomized, feasibility study aiming to evaluate the ability of a non-significant risk tissue oxygen imager based on protoporphyrin IX (PpIX) delayed fluorescence (DF) for differentiating benign from malignant skin lesions and assessing tumor margins during Mohs micrographic surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥ 18 years of age.
- •Histologic proof of non-melanoma skin cancer. Patients with different skin tones based on the Fitzpatrick Scale, who present with skin growth or lesions and are scheduled for resection.
- •As determined by the enrolling physician or study team member, the patient must have the willingness and ability to understand and comply with study procedures.
- •Women of childbearing potential (WOCBP): Premenopausal females who had at least one menstrual cycle in the past 12-months and capable to become pregnant, must have a negative serum beta-HCG pregnancy test result within seven days prior to start of study.
- •Lesions must measure between 5 mm and 3 cm in diameter.
排除标准
- •Patients who are <18 years of age
- •Adults who are unable to provide informed consent.
- •Known allergy to Ameluz
- •Photosensitivity or photodermatoses or similar conditions.
- •Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol, in the opinion of the investigator
- •Known hypersensitivity to porphyrins or to any component of Ameluz, including soya bean phosphatidylcholine.
- •Females who are currently breast-feeding
结局指标
主要结局
Detecting cutaneous malignant lesions using a non-invasive technique
时间窗: Six months after the first enrollment
Advancing our understanding of these cancers and developing effective strategies for diagnosis. The study will use aminolaevulinic acid (ALA) as a source of protoporphyrin IX (PpIX) to allow the detection of hypoxia signal. More specifically, the oxygen imager gathers the delayed fluorescence (DF) of PpIX, which intensity is inversely proportional to tissue mitochondrial oxygen content. This provides qualitative contrast on hypoxic regions with submillimeter spatial resolution. Transient hypoxia is a clear indicator of tumor tissue. We will validate the combination of hypoxia imaging with palpation as a non-invasive technique to detect cutaneous malignant lesions.
次要结局
未报告次要终点
研究者
Michael S. Chapman
Principal Investigator
Dartmouth-Hitchcock Medical Center