Bronchoscopic Laser Ablation of Peripheral Lung Tumors

Not Applicable

Terminated

Conditions: Lung Carcinoid Tumor
Metastatic Lung Carcinoma
Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8

Interventions: Procedure: Cone-Beam Computed Tomography
Procedure: Conventional Surgery
Procedure: Laser Ablation

Brief 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Diagnostic (bronchoscopic laser ablation, CBCT)	Conventional Surgery	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.
Diagnostic (bronchoscopic laser ablation, CBCT)	Cone-Beam Computed Tomography	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.
Diagnostic (bronchoscopic laser ablation, CBCT)	Laser Ablation	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.

Primary Outcome Measures

Name	Time	Method
Pathologic Changes From Bronchoscopic Laser Ablation of Peripheral Lung Tumors	Up to 16 months	Pathologic changes will be categorized into three groups: 1. Complete Ablation: absence of staining (anti-mitochondria antibody \[MAB\] 1273 or nicotinamide adenine dinucleotide-hydrogen \[NADH\], or both) of tumor cells. 2. Quasi-Complete Ablation: positive staining of 10% of tumor cells. 3. Incomplete ablation: positive staining in \> 10% of tumor cells. Will conduct extensive descriptive analyses of the data collected. Will calculate the appropriate summary statistics and 90% confidence intervals (CIs) for the measures of interest.

Secondary Outcome Measures

Name	Time	Method