Develop a High-resolution EB-OCT Platform to Visualize, Guide, Evaluate, and Increase the Accuracy of Lung Cancer Diagnosis in Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Diagnostic yield of bronchial biopsy
研究概览
简要总结
Our objective is to develop, test, and validate a clinically robust polarization-sensitive optical coherence tomography (PS-OCT) biopsy guidance and diagnosis platform that is compatible with standard bronchoscopy techniques.
详细描述
The goal of this study is to improve the unacceptably low diagnostic yield that is associated with low-risk bronchial biopsy. The investigators propose to do this by developing and optimizing a novel high-resolution optical coherence tomography (OCT) platform that will provide superior endomicroscopy images for biopsy guidance and in vivo diagnosis of lung cancer. OCT is a non-invasive imaging tool that rapidly generates high-resolution (< 10 µm) cross-sectional images of biological tissues with penetration depths approaching 2-3 mm. Polarization Sensitive OCT (PS-OCT) provides additional contrast to structural OCT by highlighting birefringent tissues such as collagen. When coupled with appropriate catheter designs OCT can be used to conduct in vivo microscopy of tissue microstructure including the detection and diagnosis of cardiovascular, gastrointestinal, and lung pathology.
The objective of this study is to develop, test, and validate a clinically robust PS-OCT biopsy guidance and diagnosis platform that is compatible with standard bronchoscopy techniques. Specifically, the investigators envision two clinical scenarios:
Biopsy Guidance:
Following the identification and gross localization of a nodule by low-dose computed tomography (LDCT), a low-risk transbronchial biopsy will be acquired for diagnosis. Placement of the biopsy catheter will be performed using standard approaches including bronchoscopy, electromagnetic navigation, or robotic bronchoscopy. The investigators will then conduct PS-OCT at the site to (1) confirm that the biopsy catheter is correctly positioned within the nodule, and (2) ensure that diagnostic-quality tissue is obtained.
OCT Diagnosis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective lung biopsy for known or suspected malignancy in the lung
- •Patients must be over the age of 21
- •Patient must be able to give informed consent
- •Negative pregnancy test for all females of childbearing potential who are sexually active and not using contraception, are seeking to become pregnant, or are nursing
排除标准
- •Patients who are pregnant
- •The patient does not meet the requirements to undergo clinical bronchoscopy, as determined by the treating physician.
结局指标
主要结局
Diagnostic yield of bronchial biopsy
时间窗: 2 years
EB-OCT guided bronchial biopsy changes the diagnostic yield when compared to traditional biopsy.
次要结局
- Determine the accuracy of OCT diagnosis of lung cancer in vivo by blinded reviewers.(2 years)
研究者
Melissa J. Suter
Associate Professor of Medicine
Massachusetts General Hospital