Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy: Discrete Pulmonary Lesions and Acute Rejection in Transplanted Lungs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 9
- 主要终点
- Development of criteria for the characterization of discrete lung lesions and for characterization of acute lung rejection in lung transplant.
研究概览
简要总结
Patients will be enrolled that are undergoing bronchoscopy for diagnosis of discrete lung lesions or for detection of acute rejection following lung transplants. The hypothesis is that bronchoscopy together with probe-based endomicroscopy (pCLE)results in improved and/or incremental diagnostic yield (definitive diagnosis) over conventional bronchoscopy.
详细描述
The primary aim of this study is to develop the criteria to differentiate healthy versus diseased tissue in patient with discrete lung lesions or to characterize acute lung rejection in patients with transplanted lungs. Once these criteria have been defined, the diagnostic parameters and the reproducibility of pCLE will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Male or female > 18 years of age
- •Willing and able to comply with study procedures and provide written informed consent to participate in the study
- •Indeterminate discrete nodule(s) suspicious for cancer scheduled for diagnostic bronchoscopy
- •Newly discovered &/or prior discovered non classified nodules, hard to define based on CT scan
- •Purpose of bronchoscopy is for diagnosis of lesion(s) - can be solitary pulmonary nodule or multiple lesions
- •All lesion locations are acceptable
- •Any patient undergoing clinically indicated bronchoscopies after lung transplantation
- •Patients post transplant showing clinical signs of acute rejection >3 weeks; < 1 year
- •Patient with single or double lung transplant
排除标准
- •Contraindication to short-acting anesthetic agents;
- •Contraindications to transbronchial biopsy
- •Bleeding diathesis;
- •A pacemaker/defibrillator;
- •A diagnosis by other means (sputum cytology, microbiology).
- •Unwilling To Consent
- •Unable To Safely Tolerate A Bronchoscopic Procedure
- •Unwilling To Comply With Surveillance Bronchoscopy Follow Up
- •Chronic Rejection
- •Fungal Disease
- •Ax Histological Assessment Or Incomplete Biopsy Procedure Should Be Considered As A Screen Failure
结局指标
主要结局
Development of criteria for the characterization of discrete lung lesions and for characterization of acute lung rejection in lung transplant.
时间窗: Up to 12 months
For Group 1 - Discrete lung lesions
Diagnostic performance of the pCLE image interpretation criteria for discrete lung lesions and for acute lung rejection in lung transplant.
时间窗: Up to 12 months.
For Group 2 - Transplant rejection
次要结局
未报告次要终点