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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 : April 6, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE October 12, 2018
First Posted Date  ICMJE October 16, 2018
Last Update Posted Date April 6, 2021
Actual Study Start Date  ICMJE September 18, 2018
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
  • Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 2 years ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bronchoscopic Laser Ablation of Peripheral Lung Tumors
Official Title  ICMJE Bronchoscopic Laser Ablation of Solid Peripheral Lung Tumors Followed by Surgical Resection (BLAST-SR Trial)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Procedure: Cone-Beam Computed Tomography
  • Procedure: Conventional Surgery
  • Procedure: Laser Ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 12, 2018)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2023
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Roberto Casal 713-792-6238 rfcasal@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03707925
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Roberto F Casal M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP