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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
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

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.

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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:
  • ABLATION, LASER
  • Photoablation


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Roberto Casal 713-792-6238 rfcasal@mdanderson.org

Locations
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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         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Roberto F Casal M.D. Anderson Cancer Center
More Information
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Additional Information:

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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

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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
Additional relevant MeSH terms:
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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