Lung DiseasesNCT05344430
MDCT vs. CBCT Guided Percutaneous Lung Nodule Biopsy: A Comparison of Pneumothorax Incidence and Associated Risk Factors
A study testing cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsy in people with Lung Diseases, run by Northwell Health at 1 site in United States.
Trial summary
The goal of this study is to determine if cone beam computed tomography (CBCT) is a viable alternative imaging guidance modality for percutaneous transthoracic needle biopsy (PTNB) in a community hospital-based practice, and to determine the incidence of CBCT PTNB-associated pneumothorax compared to multidetector… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Diseases
- What is being tested?
- cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2021to 8 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for lung biopsy at Mather Hospital's Department of Interventional Radiology.
- Patients ages from 18 years old to 90 years old.
Who cannot join
- High risk patients will be excluded from the study.
- ( High risk - Any patient with severe emphysema with bullous emphysema on baseline Computed Tomography of the Chest, intended biopsy target/nodule adjacent to an airway or central vasculature, or less than 1 cm in size)
- Patients less than 18 years old
- Patients older than 90 years old
- patients who lack mental capacity for medical decision making
- Any patient requiring or requesting general anesthesia for the intended procedure
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mather Hospital Northwell Health
Port Jefferson, New York, 11777
Kenny Lien, MD, 631-473-1320, klien@northwell.edu
Greg Haggerty, PhD, 516-551-8655, ghaggerty@northwell.edu
About this study
Official title: CT Guided and Cone Beam CT Guided Percutaneous Transthoracic Needle Biopsy: A Comparison of Pneumothorax Incidence and Associated Risk Factors
The goal of this study is to determine if cone beam computed tomography (CBCT) is a viable alternative imaging guidance modality for percutaneous transthoracic needle biopsy (PTNB) in a community hospital-based practice, and to determine the incidence of CBCT PTNB-associated pneumothorax compared to multidetector computed tomography (MDCT) guided PTNB biopsy. The standard of care in this facility is MDCT guided PTNB biopsy. The experimental arm of this study is CBCT-guided PTNB biopsy.
This prospective study will identify patients planned for PTNB. Thereafter, data on lesion characteristics, imaging findings, and clinical history will be collected. Patients will be subsequently randomly assigned to undergo biopsy using either CBCT or MDCT guidance. This study will analyze the pneumothorax incidence between groups, and assess for associations between lesion size/location, pertinent imaging findings, and clinical risk factors.
Read the detailed description
Studies have shown that CBCT is a viable imaging modality for PTNB. Although MDCT-guidance remains the preferred procedural modality, research has shown that CBCT-guided biopsies can be carried out safely and effectively. Particularly, studies demonstrate a satisfactory diagnostic yield, low complication rate, and overall reduced patient radiation dose. However, only a handful of studies have compared this method to MDCT-guided biopsy.
In this 248-bed community hospital-based interventional radiology practice, C-Arm CBCT was successfully utilized during a three-month period when a dedicated procedural CT scanner was out of service prior to the installation of a new machine. During this time, CBCT was used to perform PTNB. This study was prompted given the operators' perception that there was an overall increased incidence of biopsy-associated pneumothoraxes. Given this subjective experience, a retrospective analysis was carried out comparing the complication rate during these three months to the preceding six-month period, when MDCT-guidance was primarily used.
For the primary analysis, patients were grouped based on imaging modality (CBCT n=37; CT n=64). Multiple Pearson Chi-Square Tests were carried out using p=.05 as the statistical threshold. Additional analyses dividing patient based on lesion size (≥/< 2 cm in diameter), lesion pleural depth (≥/< 2 cm pleural depth), bullous lung change on imaging, chest tube placement, history of COPD, and smoking history were also carried out to assess for related pneumothorax risk factors.
The investigators found no significant association between the imaging modality used for PTNB and subsequent pneumothorax (p=.69). However, there was a significant interaction between chest tube placement and diagnosed chronic obstructive pulmonary disease (COPD) (p=.03), where among all study subjects, 6 of the 8 patients requiring a chest tube had a history of chronic obstructive pulmonary disease (COPD). Additionally, all patients requiring chest tube placement were either current or former smokers. This finding approached but did not reach statistical significance (p=0.12).
This study did not confirm the perceived increased pneumothorax rate. However, the findings corroborate previously published literature, where complication rates between CBCT and MDCT-guidance are reportedly comparable. This experience demonstrates that CBCT can be successfully utilized in a community hospital setting, where limited resources often prompt the need for alternative and innovative procedural approaches.
Outcomes:
To determine the incidence of pneumothorax as a complication of CBCT and CT-guided percutaneous lung biopsy.
To determine if there is an association between biopsy imaging guidance modality, lesion characteristics, and associated clinical risk factors.
To collect data that may be used in the future for biopsy modality risk stratification. This is significant, since resource allocation in community hospital settings may be necessary more frequently, compared to larger hospital settings. Therefore, proper risk stratification is needed for appropriate delivery of high quality and safe patient care.
Methods:
The Interventional Radiology department at Mather Hospital has a robust referral volume from the community oncologists and pulmonologist. In the past year, over 150 CT-guided PTNBs of the lung were performed.
The number of patients that can be recruited for this study is essentially unlimited. The only limiting factor would be the number of lung biopsies scheduled in the study institution per year.
Research protocols will be distributed to the scheduling staff to make them aware of the randomization process, to enable appropriate scheduling of research participants to the correct imaging modality and procedure room.
Outpatients scheduled for lung biopsy will be identified by the departmental interventional radiologists.
This study is exploratory in nature. As a result, the investigators are estimating that 50 patients per treatment arm is sufficient to detect a moderate effect size difference between groups.
- Conditions
- Lung Diseases
- Being tested
- cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsy
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsyProcedure or surgery
We will be conducting cone beam computer tomography for percutaneous transthoracic needle biopsies.
| Study group | Role | What they receive |
|---|---|---|
| cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsy | Other | Cone beam Computed Tomography (CBCT) with Navigational software guidance for percutaneous transthoracic needle biopsy Receives: Procedure: cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsy |
| multidetector computed tomography (MDCT) for percutaneous transthoracic needle biopsy | Other | Multidetector Computer Tomography for percutaneous transthoracic needle biopsy Receives: Procedure: cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the incidence of pneumothorax as a complication of CBCT and CT-guided percutaneous lung biopsy
rate of pneumothorax
Measured: Up to 24 hours post biopsy procedure
Secondary outcomes (3)
To compare the difference in procedure times between biopsy imaging guidance modality
Procedure time ( in minutes)
Measured: immediately after the biopsy procedure
To compare the amount of intravenous midazolam used between biopsy imaging guidance modality
Amount of Intravenous Midazolam ( in milligrams)
Measured: immediately after the biopsy procedure
To compare the the amount of intravenous fentanyl used between biopsy imaging guidance modality
Amount of intravenous Fentanyl ( in micrograms)
Measured: immediately after the biopsy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start8 Jul 2021
- Primary completion8 Jul 2024 (estimated)
- Study completion8 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenny Lien, Northwell Health
- Investigators
- Kenny Lien, MD, Principal investigator, Interventional Radiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344430
- Sponsor's protocol ID
- 20-1058-MATHER
- Status last verified
- May 2023
- First submitted
- 2 Apr 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Guided and Cone Beam CT Guided Percutaneous Transthoracic Needle Biopsy: A Comparison of Pneumothorax Incidence and Associated Risk Factors
- ClinicalTrials.gov ID
- NCT05344430
- Acronym / sponsor ID
- 20-1058-MATHER
- Conditions
- Lung Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 8 Jul 2024 (estimated)
- Study completion
- 8 Jul 2024 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine if cone beam computed tomography (CBCT) is a viable alternative imaging guidance modality for percutaneous transthoracic needle biopsy (PTNB) in a community hospital-based practice, and to determine the incidence of CBCT PTNB-associated pneumothorax compared to multidetector computed tomography (MDCT) guided PTNB biopsy. The standard of care in this facility is MDCT guided PTNB biopsy. The experimental arm of this study is CBCT-guided PTNB biopsy.
This prospective study will identify patients planned for PTNB. Thereafter, data on lesion characteristics, imaging findings, and clinical history will be collected. Patients will be subsequently randomly assigned to undergo biopsy using either CBCT or MDCT guidance. This study will analyze the pneumothorax incidence between groups, and assess for associations between lesion size/location, pertinent imaging findings, and clinical risk factors.
Detailed description
Studies have shown that CBCT is a viable imaging modality for PTNB. Although MDCT-guidance remains the preferred procedural modality, research has shown that CBCT-guided biopsies can be carried out safely and effectively. Particularly, studies demonstrate a satisfactory diagnostic yield, low complication rate, and overall reduced patient radiation dose. However, only a handful of studies have compared this method to MDCT-guided biopsy.
In this 248-bed community hospital-based interventional radiology practice, C-Arm CBCT was successfully utilized during a three-month period when a dedicated procedural CT scanner was out of service prior to the installation of a new machine. During this time, CBCT was used to perform PTNB. This study was prompted given the operators' perception that there was an overall increased incidence of biopsy-associated pneumothoraxes. Given this subjective experience, a retrospective analysis was carried out comparing the complication rate during these three months to the preceding six-month period, when MDCT-guidance was primarily used.
For the primary analysis, patients were grouped based on imaging modality (CBCT n=37; CT n=64). Multiple Pearson Chi-Square Tests were carried out using p=.05 as the statistical threshold. Additional analyses dividing patient based on lesion size (≥/< 2 cm in diameter), lesion pleural depth (≥/< 2 cm pleural depth), bullous lung change on imaging, chest tube placement, history of COPD, and smoking history were also carried out to assess for related pneumothorax risk factors.
The investigators found no significant association between the imaging modality used for PTNB and subsequent pneumothorax (p=.69). However, there was a significant interaction between chest tube placement and diagnosed chronic obstructive pulmonary disease (COPD) (p=.03), where among all study subjects, 6 of the 8 patients requiring a chest tube had a history of chronic obstructive pulmonary disease (COPD). Additionally, all patients requiring chest tube placement were either current or former smokers. This finding approached but did not reach statistical significance (p=0.12).
This study did not confirm the perceived increased pneumothorax rate. However, the findings corroborate previously published literature, where complication rates between CBCT and MDCT-guidance are reportedly comparable. This experience demonstrates that CBCT can be successfully utilized in a community hospital setting, where limited resources often prompt the need for alternative and innovative procedural approaches.
Outcomes:
To determine the incidence of pneumothorax as a complication of CBCT and CT-guided percutaneous lung biopsy.
To determine if there is an association between biopsy imaging guidance modality, lesion characteristics, and associated clinical risk factors.
To collect data that may be used in the future for biopsy modality risk stratification. This is significant, since resource allocation in community hospital settings may be necessary more frequently, compared to larger hospital settings. Therefore, proper risk stratification is needed for appropriate delivery of high quality and safe patient care.
Methods:
The Interventional Radiology department at Mather Hospital has a robust referral volume from the community oncologists and pulmonologist. In the past year, over 150 CT-guided PTNBs of the lung were performed.
The number of patients that can be recruited for this study is essentially unlimited. The only limiting factor would be the number of lung biopsies scheduled in the study institution per year.
Research protocols will be distributed to the scheduling staff to make them aware of the randomization process, to enable appropriate scheduling of research participants to the correct imaging modality and procedure room.
Outpatients scheduled for lung biopsy will be identified by the departmental interventional radiologists.
This study is exploratory in nature. As a result, the investigators are estimating that 50 patients per treatment arm is sufficient to detect a moderate effect size difference between groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsy | Other | Procedure: cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsyCone beam Computed Tomography (CBCT) with Navigational software guidance for percutaneous transthoracic needle biopsy |
| multidetector computed tomography (MDCT) for percutaneous transthoracic needle biopsy | Other | Procedure: cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsyMultidetector Computer Tomography for percutaneous transthoracic needle biopsy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for lung biopsy at Mather Hospital's Department of Interventional Radiology.
- Patients ages from 18 years old to 90 years old.
Key exclusion criteria (6 listed)
- High risk patients will be excluded from the study.
- ( High risk - Any patient with severe emphysema with bullous emphysema on baseline Computed Tomography of the Chest, intended biopsy target/nodule adjacent to an airway or central vasculature, or less than 1 cm in size)
- Patients less than 18 years old
- Patients older than 90 years old
- patients who lack mental capacity for medical decision making
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 tomography (CBCT) for percutaneous transthoracic needle biopsyWe will be conducting cone beam computer tomography for percutaneous transthoracic needle biopsies. | Procedure or surgery | cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsy, multidetector computed tomography (MDCT) for percutaneous transthoracic needle biopsy |
Primary outcome
To determine the incidence of pneumothorax as a complication of CBCT and CT-guided percutaneous lung biopsy
Time frame: Up to 24 hours post biopsy procedure
rate of pneumothorax
3 secondary outcomes
To compare the difference in procedure times between biopsy imaging guidance modality
Time frame: immediately after the biopsy procedure
To compare the amount of intravenous midazolam used between biopsy imaging guidance modality
Time frame: immediately after the biopsy procedure
To compare the the amount of intravenous fentanyl used between biopsy imaging guidance modality
Time frame: immediately after the biopsy procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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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.
Kenny Lien, MD principal investigator
Interventional Radiologist
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 (CBCT) for percutaneous transthoracic needle biopsy in people with Lung Diseases, run by Northwell Health 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenny Lien, MD (631-473-1320, klien@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the incidence of pneumothorax as a complication of CBCT and CT-guided percutaneous lung biopsy (time frame: Up to 24 hours post biopsy procedure). 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 May 2023.