Bronchoscopic Laser Ablation of Peripheral Lung Tumors

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Rėmėjai

M.D. Anderson Cancer Center

Bendradarbiai

National Cancer Institute (NCI)

KLINIKINIS TYRIMAS: NCT03707925

BioSeek: nct03707925

Raktažodžiai

Santrauka

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.

apibūdinimas

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.

Datos

Paskutinį kartą patikrinta:	06/30/2019
Pirmasis pateikimas:	10/11/2018
Numatytas registravimas pateiktas:	10/11/2018
Pirmas paskelbtas:	10/15/2018
Paskutinis atnaujinimas pateiktas:	07/07/2019
Paskutinis atnaujinimas paskelbtas:	07/09/2019
Faktinė studijų pradžios data:	09/17/2018
Numatoma pirminio užbaigimo data:	10/30/2020
Numatoma studijų užbaigimo data:	10/30/2021

Būklė ar liga

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

Intervencija / gydymas

Procedure: Diagnostic (bronchoscopic laser ablation, CBCT)

Fazė

Rankų grupės

Ranka	Intervencija / gydymas
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: Diagnostic (bronchoscopic laser ablation, CBCT) Undergo CBCT

Tinkamumo kriterijai

Amžius, tinkami studijuoti	18 Years Į 18 Years
Tinkamos studijoms lytys	All
Priima sveikus savanorius	Taip
Kriterijai	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

Rezultatas

Pirminės rezultatų priemonės

1. Pathologic changes from bronchoscopic laser ablation of peripheral lung tumors [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.

Antrinės rezultatų priemonės

1. Incidence of adverse events [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 [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) [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.

Bronchoscopic Laser Ablation of Peripheral Lung Tumors

Raktažodžiai

plaučių vėžys

pneumonia

vėžys

kraujavimas

karščiavimas

pneumothorax