Trial Outcomes & Findings for Bronchoscopic Laser Ablation of Peripheral Lung Tumors (NCT NCT03707925)

Last Updated: 2023-02-16

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

Up to 16 months

Results posted on

2023-02-16

Participant Flow

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.

4 participants consented, 1 inevaluable

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Inevaluable	1

Baseline Characteristics

Bronchoscopic Laser Ablation of Peripheral Lung Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bronchoscopic Laser Ablation, Cone-beam CT(CBCT) n=4 Participants 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
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=93 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	4 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 16 months

Population: Only patients who underwent bronchoscopic tumor ablation are included in the analysis.

Outcome measures

Outcome measures
Measure	Bronchoscopic Laser Ablation, Cone-beam CT(CBCT) n=3 Participants 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
Pathologic Changes From Bronchoscopic Laser Ablation of Peripheral Lung Tumors Complete Ablation	0 Participants
Pathologic Changes From Bronchoscopic Laser Ablation of Peripheral Lung Tumors Quasi-Complete Ablation	0 Participants
Pathologic Changes From Bronchoscopic Laser Ablation of Peripheral Lung Tumors Incomplete Ablation	3 Participants

Adverse Events

Bronchoscopic Laser Ablation, Cone-beam CT(CBCT)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bronchoscopic Laser Ablation, Cone-beam CT(CBCT) n=4 participants at risk 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
Respiratory, thoracic and mediastinal disorders Pneumothorax	25.0% 1/4 • up to 16 months Serious adverse effects" (SAE) are defined as pneumothorax requiring chest tube, bleeding requiring balloon tamponade or leading to respiratory failure, hypoxemia (SpaO2 \<90% for \> 1 min) during bronchoscopy, post-bronchoscopy pneumonitis with need of supplemental oxygen.

Other adverse events

Adverse event data not reported

Additional Information

Roberto Casal, MD/ Associate Professor, Pulmonary Medicine

UT MD Anderson Cancer Center

Phone: 713-745-2645

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place