Bronchoscopic Laser Ablation of Peripheral Lung Tumors
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/18/2018 |
| Start Date: | September 18, 2018 |
| End Date: | October 31, 2020 |
| Contact: | Roberto Casal |
| Email: | rfcasal@mdanderson.org |
| Phone: | 713-792-6238 |
Bronchoscopic Laser Ablation of Solid Peripheral Lung Tumors Followed by Surgical Resection (BLAST-SR Trial)
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.
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.
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 (CB) 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.
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 (CB) 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.
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
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Roberto F. Casal
Phone: 713-792-6238
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