Optical Coherence Tomography: An Adjunct to Flexible Bronchoscopy in the Diagnosis of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- OCT image sensitivity and specificity in diagnosis of lung cancer.
研究概览
简要总结
Optical coherence tomography will be a feasible adjunct to flexible bronchoscopy, and provide images with good sensitivity and specificity to determine the presence of endobronchial malignancies.
详细描述
OCT could become a powerful tool in diagnostic pulmonary medicine, not only in the early recognition of lung cancer, but also in the evaluation and monitoring of microstructures in the lower respiratory tract that are affected by other inflammatory or invasive disease processes. Initially, OCT could be used to guide the location of biopsies which would likely provide increased specificity to traditional bronchoscopy. However, if the sensitivity and specificity of OCT images are comparable to histologic specimens, this technology may in the future provide a non-invasive "optical biopsy", which could potentially obviate the need for conventional biopsies in patients with high risks for complications, such as bleeding.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subjects 18-99 years of age
- •Presence of an endobronchial mass
- •Need for flexible bronchoscopy, with endobronchial biopsies
排除标准
- •PCO2 > 47 mm Hg, and/or long term Oxygen therapy
- •Unwillingness to undergo fiberoptic bronchoscopy
- •Coagulopathy, defined as a platelets count < 100.000/mm3, or an INR> 1.4, or known clinical bleeding disorder
- •Therapy with anticoagulant, including Coumadin and Clopidogrel
- •Renal dysfunction, defined as a Creatinine > 2 mg/dl
- •Life-threatening arrhythmias, or history of myocardial infarction within 6 months
- •Cerebrovascular Accident within the preceding 6 months
- •Facial abnormality preventing safe introduction of the bronchoscope
- •Uncontrolled hypertension
- •Active liver disease
- •Pregnancy or Breastfeeding
- •Prisoners
- •Inability to give informed consent
结局指标
主要结局
OCT image sensitivity and specificity in diagnosis of lung cancer.
时间窗: Every 3 months
次要结局
- Feasibility and safety of obtaining OCT images during flexible bronchoscopy.(Every 3 months)
研究者
Gary Kinasewitz
Principal Investigator
University of Oklahoma