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
Conditions
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.
Interventions
PROCEDURECone-Beam Computed Tomography
Undergo CBCT
PROCEDUREConventional Surgery
Undergo standard resection
PROCEDURELaser Ablation
Undergo bronchoscopic laser ablation
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Changes From Bronchoscopic Laser Ablation of Peripheral Lung Tumors | Up to 16 months | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Department of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center and the Gynecologic Oncology Clinics in the Regional Care Centers.
Pre-assignment details
4 participants consented, 1 inevaluable
Participants by arm
| Arm | Count |
|---|---|
| Bronchoscopic Laser Ablation, Cone-beam CT(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.
Cone-Beam Computed Tomography: Undergo CBCT
Conventional Surgery: Undergo standard resection
Laser Ablation: Undergo bronchoscopic laser ablation | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Inevaluable | 1 |
Baseline characteristics
| Characteristic | Bronchoscopic Laser Ablation, Cone-beam CT(CBCT) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 1 / 4 |
Outcome results
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.
Time frame: Up to 16 months
Population: Only patients who underwent bronchoscopic tumor ablation are included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bronchoscopic Laser Ablation, Cone-beam CT(CBCT) | Pathologic Changes From Bronchoscopic Laser Ablation of Peripheral Lung Tumors | Complete Ablation | 0 Participants |
| Bronchoscopic Laser Ablation, Cone-beam CT(CBCT) | Pathologic Changes From Bronchoscopic Laser Ablation of Peripheral Lung Tumors | Quasi-Complete Ablation | 0 Participants |
| Bronchoscopic Laser Ablation, Cone-beam CT(CBCT) | Pathologic Changes From Bronchoscopic Laser Ablation of Peripheral Lung Tumors | Incomplete Ablation | 3 Participants |