PILOT STUDY OF THE CORRELATION BETWEEN THE FINDINGS OF ATYPICAL/MALIGNANT CELLS IN SPUTUM AND FLUORESCENCE BRONCHOSCOPY IN PATIENTS AT RISK FOR LUNG CANCER OF THE LIFE IMAGING SYSTEM AND WHITE LIGHT BRONCHOSCOPY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Fluorescent bronchoscopy, when used in combination with conventional white light bronchoscopy, may improve the ability to detect early lung cancer.
PURPOSE: A pilot study to evaluate fluorescent light bronchoscopy plus conventional bronchoscopy as a tool for screening and detecting lung cancer in persons with completely resected head and neck cancer or successfully treated early-stage lung cancer.
详细描述
OBJECTIVES:
- Evaluate the efficacy of autofluorescence bronchoscopy using the Lung Imaging Fluorescence Endoscopic System with conventional white-light bronchoscopy for the early detection of lung cancer in selected patients with known or suspected bronchogenic carcinoma, completely resected head and neck cancer, and successfully treated early-stage lung cancer.
- Determine the number of areas of moderate dysplasia, severe dysplasia, and carcinoma in situ in patients treated with surgery for lung cancer compared with patients treated with combined modality therapy.
- Determine the ability of immunohistochemistry to predict whether lesions of moderate to severe dysplasia will progress to cancer.
OUTLINE: If possible, patients produce a 3-day pooled sputum sample prior to bronchoscopy. Patients then undergo tracheobronchial white-light bronchoscopy followed by autofluorescence bronchoscopy using the Lung Imaging Fluorescence Endoscopic (LIFE) Device attached to a computerized video camera. Visualized tissue is classified as either normal, abnormal, or suspicious. Abnormal or suspicious tissue is biopsied, as is tissue from 1 or 2 randomly chosen normal sites. Immunohistochemical analysis of the biopsy material is conducted without knowledge of the bronchoscopic results. Patients unable to produce a sputum sample prior to bronchoscopy are required to do so after bronchoscopy.
PROJECTED ACCRUAL: A total of 70 patients will be entered.
研究设计
- 研究类型
- Interventional
- 主要目的
- Screening
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
- •DISEASE CHARACTERISTICS:
- •The following diagnoses are eligible:
- •Known or suspected bronchogenic carcinoma scheduled for bronchoscopy as part of standard diagnostic or staging work-up
- •Completely resected stage I/II non-small cell lung cancer with no evidence of metastasis
- •Stage III non-small cell lung cancer with no evidence of disease for at least 2 years following treatment
- •Small cell lung cancer with no evidence of disease for at least 2 years following treatment
- •Completely resected head and neck cancer with no evidence of metastasis
- •Ability to produce sputum samples required
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Hematopoietic:
- •WBC 2,000-20,000
- •Platelets at least 50,000
- •Not specified
- •Not specified
- •Cardiovascular:
- •No uncontrolled hypertension (i.e., systolic pressure greater than 200 mm Hg or diastolic pressure greater than 120 mm Hg)
- •No unstable angina
- •No bleeding disorder
- •No allergic reaction to topical lidocaine
- •No pregnant women
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •At least 18 months since ionizing radiotherapy to the chest
- •See Disease Characteristics
- •At least 1 month since yttrium-aluminum-garnet (YAG) laser therapy to the lung
- •At least 3 months since fluorescent photosensitizing drugs (e.g., Photofrin)
排除标准
- 未提供