Bronchoscopic Laser Ablation of Peripheral Lung Tumors
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ClinicalTrials.gov Identifier: NCT03707925 |
Recruitment Status :
Recruiting
First Posted : October 16, 2018
Last Update Posted : July 10, 2019
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Condition or disease | Intervention/treatment | Phase |
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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 | Procedure: Cone-Beam Computed Tomography Procedure: Conventional Surgery Procedure: Laser Ablation | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Bronchoscopic Laser Ablation of Solid Peripheral Lung Tumors Followed by Surgical Resection (BLAST-SR Trial) |
Actual Study Start Date : | September 18, 2018 |
Estimated Primary Completion Date : | October 31, 2020 |
Estimated Study Completion Date : | October 31, 2021 |

Arm | Intervention/treatment |
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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.
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Procedure: Cone-Beam Computed Tomography
Undergo CBCT
Other Name: Cone Beam CT Procedure: Conventional Surgery Undergo standard resection Procedure: Laser Ablation Undergo bronchoscopic laser ablation
Other Names:
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- Pathologic changes from bronchoscopic laser ablation of peripheral lung tumors [ Time Frame: Up to 2 years ]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.
- Incidence of adverse events [ Time Frame: Up to 2 years ]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.
- Pathologic changes observed in the lung tissue surrounding the treated lung tumor [ Time Frame: Up to 2 years ]Will conduct extensive descriptive analyses of the data collected. Will calculate the appropriate summary statistics and 90% CIs for the measures of interest.
- Radiographic changes observed by cone-beam computed tomography (CT) [ Time Frame: At completion of bronchoscopic laser ablation ]Will conduct extensive descriptive analyses of the data collected. Will calculate the appropriate summary statistics and 90% CIs for the measures of interest.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707925
Contact: Roberto Casal | 713-792-6238 | rfcasal@mdanderson.org |
United States, Texas | |
M D Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Roberto F. Casal 713-792-6238 | |
Principal Investigator: Roberto F. Casal |
Principal Investigator: | Roberto F Casal | M.D. Anderson Cancer Center |
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT03707925 |
Other Study ID Numbers: |
2018-0474 NCI-2018-02133 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2018-0474 ( Other Identifier: M D Anderson Cancer Center ) P30CA016672 ( U.S. NIH Grant/Contract ) |
First Posted: | October 16, 2018 Key Record Dates |
Last Update Posted: | July 10, 2019 |
Last Verified: | July 2019 |
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 |
Carcinoma Lung Neoplasms Carcinoid Tumor Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Lung Diseases Respiratory Tract Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Adenocarcinoma Neoplasms, Nerve Tissue Carcinoma, Bronchogenic Bronchial Neoplasms |