Lung Carcinoid TumorNCT03707925
Bronchoscopic Laser Ablation of Peripheral Lung Tumors
A study testing Cone-Beam Computed Tomography, Conventional Surgery and Laser Ablation in people with Lung Carcinoid Tumor and Lung Non-Small Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Carcinoid Tumor, Lung Non-Small Cell Carcinoma, Metastatic Lung Carcinoma
- What is being tested?
- Cone-Beam Computed Tomography, Conventional Surgery and Laser Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2018to 20 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- 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
- Being tested
- Cone-Beam Computed Tomography, Conventional Surgery, Laser Ablation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone-Beam Computed TomographyProcedure or surgery
Also called Cone Beam CT
Undergo CBCT
Conventional SurgeryProcedure or surgery
Undergo standard resection
Laser AblationProcedure or surgery
Also called ABLATION, LASER, Photoablation
Undergo bronchoscopic laser ablation
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (bronchoscopic laser ablation, CBCT) | Experimental | 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. Receives: Procedure: Cone-Beam Computed Tomography; Procedure: Conventional Surgery; Procedure: Laser Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start18 Sep 2018
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Why it stopped: Very slow accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung Carcinoid TumorStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Roberto F Casal, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707925
- Sponsor's protocol ID
- 2018-0474
- Other IDs
- NCI-2018-02133, 2018-0474
- Status last verified
- Jan 2023
- First submitted
- 12 Oct 2018
- Last updated
- 16 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopic Laser Ablation of Solid Peripheral Lung Tumors Followed by Surgical Resection (BLAST-SR Trial)
- ClinicalTrials.gov ID
- NCT03707925
- Acronym / sponsor ID
- 2018-0474
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very slow accrual rate
- Enrolment
- 4 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Posted 16 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (bronchoscopic laser ablation, CBCT) | Experimental | Procedure: Cone-Beam Computed Tomography, Procedure: Conventional Surgery, Procedure: Laser AblationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cone-Beam Computed TomographyAlso: Cone Beam CTUndergo CBCT | Procedure or surgery | Diagnostic (bronchoscopic laser ablation, CBCT) |
| Conventional SurgeryUndergo standard resection | Procedure or surgery | Diagnostic (bronchoscopic laser ablation, CBCT) |
| Laser AblationAlso: ABLATION, LASER, PhotoablationUndergo bronchoscopic laser ablation | Procedure or surgery | Diagnostic (bronchoscopic laser ablation, CBCT) |
Primary outcome
Pathologic Changes From Bronchoscopic Laser Ablation of Peripheral Lung Tumors
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto F Casal principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cone-Beam Computed Tomography, Conventional Surgery and Laser Ablation in people with Lung Carcinoid Tumor and Lung Non-Small Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Changes From Bronchoscopic Laser Ablation of Peripheral Lung Tumors (time frame: Up to 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.