Bronchoscopic Laser Ablation of Peripheral Lung Tumors

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.

• Cone-Beam Computed Tomography (Procedure), also known as Cone Beam CT: Undergo CBCT
• Conventional Surgery (Procedure): Undergo standard resection
• Laser Ablation (Procedure), also known as ABLATION, LASER, Photoablation: Undergo bronchoscopic laser ablation

Primary outcomes

• 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.

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Pathologic Changes From Bronchoscopic Laser Ablation of Peripheral Lung Tumors (Primary), Count of participants, Participants: Bronchoscopic Laser Ablation, Cone-beam CT(CBCT) 0

Adverse events

Time frame: up to 16 months

Serious adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2019-02-19)

• Roberto F Casal, Principal investigator, M.D. Anderson Cancer Center