NCT01611584撤回1 期
A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- ALA-induced fluorescence- lung cancer
研究概览
简要总结
The purpose of this trial is to measure ALA-induced fluorescence in both normal and malignant tissue.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria Patients (12 total patients with lung cancer) meeting eligibility criteria will be enrolled.
- •Preoperative diagnosis of either presumed or documented non-small cell lung cancer.
- •Tumor judged to be suitable for surgical resection based on preoperative evaluation of radiographic studies, pulmonary function tests, performance status and clinical judgment of surgeons at DHMC (Erkmen, Nugent)
- •Age ≥ 18 years old.
- •Population representative of our usual referral pattern including minority populations, women and those who are financially disadvantaged.
- •Subjects capable of giving informed consent
排除标准
- •Pregnant Women
- •Women who are breast feeding
- •History of cutaneous photosensitivity
- •Porphyria, hypersensitivity to porphyrins, photodermatosis
- •Exfoliative dermatitis
- •History of liver disease within the last 12 months
- •Inability to comply with photosensitivity precautions associated with the study
- •Inability to give informed consent
- •AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit at any time during the past 2 months
- •Plasma creatinine in excess of 180 umol/L
- •Women who are breast feeding
- •History of cutaneous photosensitivity
- •Porphyria, hypersensitivity to porphyrins, photodermatosis
- •Exfoliative dermatitis
- •History of liver disease within the last 12 months
- •Inability to comply with photosensitivity precautions associated with the study
研究组 & 干预措施
ALA
Experimental
No arms for the trial. Participants will have proven or presumed lung cancer and will be assessed for participant by a research team member.
干预措施: ALA-induced Fluorescence (Drug)
结局指标
主要结局
ALA-induced fluorescence- lung cancer
时间窗: Participants will be followed for duration of the hospital stay, and up to 3 weeks after
Determine the relationship between ALA induced protoporphyrin IX (PplX) flourescence and histology in both normal and malignant tumors.
次要结局
- Determine Feasibility of fluorescence(Participants will be followed for the duration of their hospital study and up to 3 weeks after)
研究者
研究点 (1)
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