Bronchoscopic Laser Ablation of Peripheral Lung Tumors

Stage IV Lung Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03707925
• Other study ID #: 2018-0474
• Secondary ID: NCI-2018-0213320
• Status: Terminated
• Phase: N/A
• Start date: September 18, 2018
• Est. completion date: January 20, 2022

Study information

• Verified date: January 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Carcinoid Tumor
• Lung Neoplasms
• 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

Intervention

Procedure:
• Cone-Beam Computed Tomography
Undergo CBCT
• Conventional Surgery
Undergo standard resection
• Laser Ablation
Undergo bronchoscopic laser ablation

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   MD Anderson Cancer Center Website