Lung CarcinomaNCT05059691
Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy
An observational study of Lung Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study assesses the effectiveness of transbronchial cryobiopsy guided by 3-dimensional fluoroscopy. Transbronchial cryobiopsy is a procedure to collect lung tissue. The main side effect seen after a transbronchial cryobiopsy is pneumothorax (air leaking out of the lung, which may cause a completely or partially… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Electronic Health Record Review and Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2021to 11 May 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with presence of an intraparenchymal lung lesion for which cryobiopsy is deemed the most appropriate method of biopsy
Who may be able to join
- Age 18 years or older
- Presence of an intraparenchymal lung lesion for which cryobiopsy is deemed the most appropriate method of biopsy
- Ability to provide informed consent
Who cannot join
- Acute respiratory failure (defined as oxygen requirement > 4 L/min by nasal cannula above baseline, or need for any intervention to support ventilation and/or gas exchange for any duration, including invasive and non-invasive positive pressure ventilation, high-flow therapy, non-rebreather mask, or Venturi mask)
- Intensive care unit (ICU) admission
- Forced vital capacity (FVC) < 50% or diffusing capacity of the lung for carbon monoxide (CO) (DLCO) < 35% (if pulmonary function tests are available)
- Known or suspected pulmonary hypertension (defined as elevated right ventricular systolic pressure on echocardiogram, if available)
- Acute renal failure or chronic kidney disease
- Platelets < 100,000/uL
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- International normalized ratio (INR) > 1.5
- Use of anticoagulant therapy that cannot be held for 2 days
- Use of antiplatelet therapy (other than baby aspirin) that cannot be held for 5 days
- Any bleeding diathesis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy, a Prospective Pilot Study
This study assesses the effectiveness of transbronchial cryobiopsy guided by 3-dimensional fluoroscopy. Transbronchial cryobiopsy is a procedure to collect lung tissue. The main side effect seen after a transbronchial cryobiopsy is pneumothorax (air leaking out of the lung, which may cause a completely or partially collapsed lung). The standard imaging scans used during this procedure are 2-dimensional (like a photo), which can make it difficult for the doctor to know exactly where the biopsy tool is during the procedure. If the exact location of the device is not clear, a patient can be at a higher risk of pneumothorax. Using a 3-dimensional imaging technique may help to decrease the risk of pneumothorax during transbronchial cryobiopsy.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine if transbronchial cryobiopsy guided by three-dimensional fluoroscopy reduces the incidence of pneumothorax up to 72 hours after transbronchial cryobiopsy.
SECONDARY OBJECTIVE:
- To describe outcomes of cryobiopsy, need for interventions related to transbronchial cryobiopsy, radiation dose, and any complications or adverse events after transbronchial cryobiopsy guided by three-dimensional fluoroscopy.
OUTLINE:
Patients undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy. Patients' medical records are also reviewed.
- Conditions
- Lung Carcinoma
- Being tested
- Electronic Health Record Review, Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Review of medical records
Transbronchial Cryobiopsy Guided by Three-Dimensional FluoroscopyProcedure or surgery
Undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy
| Study group | Role | What they receive |
|---|---|---|
| Observational (transbronchial cryobiopsy) | Patients undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy. Patients' medical records are also reviewed. Receives: Other: Electronic Health Record Review; Procedure: Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pneumothorax
The proportion of patients developing pneumothorax will be compared with the proportion in the historical control (i.e., 20%) using two-sided binomial test. A p-value of less than 0.05 will indicate a statistical significance. The proportion of patients identified as developing pneumothorax and its exact 95% confidence interval will be estimated. Poisson regression model will be used to estimate the incidence of pneumothorax accounting for the number of biopsy sites.
Measured: Up to 72 hours after cryobiopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start30 Mar 2021
- Primary completion11 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce F Sabath, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059691
- Sponsor's protocol ID
- 2020-1174
- Other IDs
- NCI-2021-08947, 2020-1174
- Status last verified
- May 2023
- First submitted
- 10 Sep 2021
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy, a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT05059691
- Acronym / sponsor ID
- 2020-1174
- Conditions
- Lung Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 28 Sep 2021 (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.
This study assesses the effectiveness of transbronchial cryobiopsy guided by 3-dimensional fluoroscopy. Transbronchial cryobiopsy is a procedure to collect lung tissue. The main side effect seen after a transbronchial cryobiopsy is pneumothorax (air leaking out of the lung, which may cause a completely or partially collapsed lung). The standard imaging scans used during this procedure are 2-dimensional (like a photo), which can make it difficult for the doctor to know exactly where the biopsy tool is during the procedure. If the exact location of the device is not clear, a patient can be at a higher risk of pneumothorax. Using a 3-dimensional imaging technique may help to decrease the risk of pneumothorax during transbronchial cryobiopsy.
Detailed description
PRIMARY OBJECTIVE:
- To determine if transbronchial cryobiopsy guided by three-dimensional fluoroscopy reduces the incidence of pneumothorax up to 72 hours after transbronchial cryobiopsy.
SECONDARY OBJECTIVE:
- To describe outcomes of cryobiopsy, need for interventions related to transbronchial cryobiopsy, radiation dose, and any complications or adverse events after transbronchial cryobiopsy guided by three-dimensional fluoroscopy.
OUTLINE:
Patients undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy. Patients' medical records are also reviewed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (transbronchial cryobiopsy) | – | Other: Electronic Health Record Review, Procedure: Transbronchial Cryobiopsy Guided by Three-Dimensional FluoroscopyPatients undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy. Patients' medical records are also reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with presence of an intraparenchymal lung lesion for which cryobiopsy is deemed the most appropriate method of biopsy
Key inclusion criteria (3 listed)
- Age 18 years or older
- Presence of an intraparenchymal lung lesion for which cryobiopsy is deemed the most appropriate method of biopsy
- Ability to provide informed consent
Key exclusion criteria (11 listed)
- Acute respiratory failure (defined as oxygen requirement > 4 L/min by nasal cannula above baseline, or need for any intervention to support ventilation and/or gas exchange for any duration, including invasive and non-invasive positive pressure ventilation, high-flow therapy, non-rebreather mask, or Venturi mask)
- Intensive care unit (ICU) admission
- Forced vital capacity (FVC) < 50% or diffusing capacity of the lung for carbon monoxide (CO) (DLCO) < 35% (if pulmonary function tests are available)
- Known or suspected pulmonary hypertension (defined as elevated right ventricular systolic pressure on echocardiogram, if available)
- Acute renal failure or chronic kidney disease
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 |
|---|---|---|
| Electronic Health Record ReviewReview of medical records | Other | Observational (transbronchial cryobiopsy) |
| Transbronchial Cryobiopsy Guided by Three-Dimensional FluoroscopyUndergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy | Procedure or surgery | Observational (transbronchial cryobiopsy) |
Primary outcome
Incidence of pneumothorax
Time frame: Up to 72 hours after cryobiopsy
The proportion of patients developing pneumothorax will be compared with the proportion in the historical control (i.e., 20%) using two-sided binomial test. A p-value of less than 0.05 will indicate a statistical significance. The proportion of patients identified as developing pneumothorax and its exact 95% confidence interval will be estimated. Poisson regression model will be used to estimate the incidence of pneumothorax accounting for the number of biopsy sites.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- 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.
Bruce F Sabath 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?
An observational study of Lung 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 15 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of pneumothorax (time frame: Up to 72 hours after cryobiopsy). 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 15 May 2023.