NCT03707925

Bronchoscopic Laser Ablation of Peripheral Lung Tumors

Bronchoscopic Laser Ablation of Solid Peripheral Lung Tumors Followed by Surgical Resection (BLAST-SR Trial)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Cone-Beam Computed Tomography	Undergo CBCT
PROCEDURE	Conventional Surgery	Undergo standard resection
PROCEDURE	Laser Ablation	Undergo bronchoscopic laser ablation

Timeline

• Start date: 2018-09-18
• Primary completion: 2022-01-20
• Completion: 2022-01-20
• First posted: 2018-10-16
• Last updated: 2023-02-16
• Results posted: 2023-02-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study