Bronchoscopic Laser Ablation of Peripheral Lung Tumors

NCT03707925 | Terminated Results FDA Device

• 2 other identifiers: 2018-0474NCI-2018-02133
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Diagnostic (bronchoscopic laser ablation, CBCT)

EXPERIMENTAL

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; Procedure: Conventional Surgery; Procedure: Laser Ablation

Interventions

Cone-Beam Computed Tomography PROCEDURE

Undergo CBCT

Also known as: Cone Beam CT

Diagnostic (bronchoscopic laser ablation, CBCT)

Conventional Surgery PROCEDURE

Undergo standard resection

Diagnostic (bronchoscopic laser ablation, CBCT)

Laser Ablation PROCEDURE

Undergo bronchoscopic laser ablation

Also known as: ABLATION, LASER, Photoablation

Diagnostic (bronchoscopic laser ablation, CBCT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Roberto Casal, MD/ Associate Professor, Pulmonary Medicine
• Organization: UT MD Anderson Cancer Center

rfcasal@mdanderson.org

713-745-2645

Study Officials

• Roberto F Casal

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 16, 2018
• Study Start: September 18, 2018
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: February 16, 2023
• Results First Posted: February 16, 2023

Record last verified: 2023-01

Locations

US (1)