Bronchoscopic Laser Ablation of Peripheral Lung Tumors

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

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.

Study Overview

• Status: Terminated
• Conditions: Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Lung Non-Small Cell Carcinoma; Metastatic Lung Carcinoma; Stage IV Lung Cancer AJCC v8; Lung Carcinoid Tumor
• Intervention / Treatment: Procedure: Cone-Beam Computed Tomography; Procedure: Conventional Surgery; Procedure: Laser Ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (bronchoscopic laser ablation, CBCT); 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.	Procedure: Cone-Beam Computed Tomography; Undergo CBCT; Other Names: Cone Beam CT; Procedure: Conventional Surgery; Undergo standard resection; Procedure: Laser Ablation; Undergo bronchoscopic laser ablation; Other Names: ABLATION, LASER; Photoablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic Changes From Bronchoscopic Laser Ablation of Peripheral Lung Tumors	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.	Up to 16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE). Will be measured by serious adverse effects (SAE), defined as pneumothorax requiring chest tube, bleeding requiring balloon tamponade or leading to respiratory failure, and hypoxemia during bronchoscopy, post-bronchoscopy pneumonitis with need of supplemental oxygen.	Up to 2 years
Pathologic changes observed in the lung tissue surrounding the treated lung tumor	Will conduct extensive descriptive analyses of the data collected. Will calculate the appropriate summary statistics and 90% CIs for the measures of interest.	Up to 2 years
Radiographic changes observed by cone-beam computed tomography (CT)	Will conduct extensive descriptive analyses of the data collected. Will calculate the appropriate summary statistics and 90% CIs for the measures of interest.	At completion of bronchoscopic laser ablation

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2018
• Primary Completion (Actual): January 20, 2022
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma; Carcinoid Tumor
• Other Study ID Numbers: 2018-0474 (Other Identifier: M D Anderson Cancer Center); NCI-2018-02133 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No