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Bronchoscopic Laser Ablation of Peripheral Lung Tumors

Primary Purpose

Lung Carcinoid Tumor, Lung Non-Small Cell Carcinoma, Metastatic Lung Carcinoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cone-Beam Computed Tomography
Conventional Surgery
Laser Ablation
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Carcinoid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (bronchoscopic laser ablation, CBCT)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 12, 2018
Last Updated
January 19, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03707925
Brief Title
Bronchoscopic Laser Ablation of Peripheral Lung Tumors
Official Title
Bronchoscopic Laser Ablation of Solid Peripheral Lung Tumors Followed by Surgical Resection (BLAST-SR Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Very slow accrual rate
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
January 20, 2022 (Actual)
Study Completion Date
January 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (bronchoscopic laser ablation, CBCT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cone-Beam Computed Tomography
Other Intervention Name(s)
Cone Beam CT
Intervention Description
Undergo CBCT
Intervention Type
Procedure
Intervention Name(s)
Conventional Surgery
Intervention Description
Undergo standard resection
Intervention Type
Procedure
Intervention Name(s)
Laser Ablation
Other Intervention Name(s)
ABLATION, LASER, Photoablation
Intervention Description
Undergo bronchoscopic laser ablation
Primary Outcome Measure Information:
Title
Pathologic Changes From Bronchoscopic Laser Ablation of Peripheral Lung Tumors
Description
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.
Time Frame
Up to 16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto F Casal
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

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Bronchoscopic Laser Ablation of Peripheral Lung Tumors

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