Lung Cancer Clinical Trial
Bronchoscopic Laser Ablation of Peripheral Lung Tumors
Summary
As our population ages and we diagnose early lung cancer in patients who cannot undergo surgery due to multiple medical conditions, there is growing interest in minimally invasive modalities to treat these tumors. In this study we are assessing the ability of bronchoscopic laser ablation to kill the cancer cells in these tumors. Patients will undergo bronchoscopy (a tube-like instrument inserted through the mouth to view the inside of the trachea, air passages, and lungs). A thin catheter will be passed through the wind-pipes and into the lung tumor with computed tomography guidance. A laser probe is then passed through this catheter and it is used to destroy the tumor with heat. Patients will then undergo lung surgery with resection of the tumor, and the resected specimen will be reviewed to describe the amount of tumor-kill produced by the laser.
Full Description
PRIMARY OBJECTIVES:
I. To assess the pathologic changes that result from bronchoscopic laser ablation of peripheral lung tumors focusing on the proportion of complete tumor ablation.
SECONDARY OBJECTIVES:
I. To assess the safety of this technique by describing both procedure-related complications such as bleeding or pneumothorax and post-procedure adverse effects such as fever or pneumonitis.
II. To assess the pathologic changes observed in the lung tissue surrounding the treated lung tumor.
III. To assess radiographic changes observed by cone-beam computed tomography (CT) immediately after the application of bronchoscopic laser ablation.
OUTLINE:
Patients undergo bronchoscopic laser ablation following standard bronchoscopy and endobronchial ultrasound. Patients also undergo CBCT before and after laser ablation. 48-72 hours after the procedure, patients undergo standard surgical resection of the lung tumor.
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Performance status 0-2 (Eastern Cooperative Oncology Group classification)
Subject is considered a candidate for bronchoscopy
Subject is considered a candidate for surgery (other lobar or sub-lobar resection) based on radiographic staging and functional evaluation
Lung lesion that is either biopsy-proven cancer or is suspicious for cancer
Both non-small cell lung cancer (including carcinoid tumors) and metastatic disease
The lesions should be: =< 3 cm, located in the outer 2/3 of the lung, and leave >= 1 cm of tumor-free lung parenchyma between target tumor and pleura or fissure
Exclusion Criteria:
Tumors greater than 3 cm, located in the inner 1/3 of the lung, invading a major vessel, or located < 1 cm from the pleural or fissure
Tumors qualified as non-resectable
Tumors that cannot be reached bronchoscopically
Patients declared non-surgical candidates
Patients who are not candidates for bronchoscopy
Patients with lung cancer who are found to have N2-3 disease
Patient with lung metastases who are found to have any malignant mediastinal lymph node
Patients in which the target lesion is confirmed as benign or small cell lung cancer
Patients without a prior diagnosis of the target lesion whose diagnosis cannot be made during bronchoscopy
Patients who have received chemotherapy within 60 days prior to bronchoscopic laser ablation
Patients who were previously treated for the target lesion
Pregnant patients
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Houston Texas, 77030, United States
How clear is this clinincal trial information?