Bronchoscopic Laser Ablation of Peripheral Lung Tumors

NCT ID: NCT03707925

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-18
• Study Completion Date: 2022-01-20

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cone-Beam Computed Tomography

Intervention Type: PROCEDURE

Undergo CBCT

Conventional Surgery

Intervention Type: PROCEDURE

Undergo standard resection

Laser Ablation

Intervention Type: PROCEDURE

Undergo bronchoscopic laser ablation

Interventions

Cone-Beam Computed Tomography

Undergo CBCT

Intervention Type: PROCEDURE

Conventional Surgery

Undergo standard resection

Intervention Type: PROCEDURE

Laser Ablation

Undergo bronchoscopic laser ablation

Intervention Type: PROCEDURE

Other Intervention Names

Cone Beam CT; ABLATION, LASER; Photoablation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto F Casal

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

NCI-2018-02133

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-0474

Identifier Type: OTHER

Identifier Source: secondary_id

2018-0474

Identifier Type: -

Identifier Source: org_study_id