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Lung NeoplasmNCT04995172

Feasibility of Mobile-CT-Assisted Bronchoscopy for the Diagnosis of Lung Lesion

An observational study of Lung Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigates whether using a mobile-CT-assisted bronchoscopy (M-CAB) during a bronchoscopy procedure will better enable the study staff to reach the lung tumor, perform a biopsy, and obtain a diagnosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Neoplasm
What is being tested?
Computed Tomography, Electronic Health Record Review and Endobronchial Ultrasound Bronchoscopy
Type of treatment
Surgery or procedure
How many people
72 participants
Where
1 siteUnited States
Study dates
19 Apr 2021to 27 Nov 2024
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 diagnosed with a peripheral lung lesion who are scheduled to undergo a bronchoscopy

Who may be able to join

  • Patients of 18 years of age or older undergoing bronchoscopy for diagnosis of a peripheral lung lesion from 1 to 3.5 cm in diameter located in the outer 2/3 of the lung fields

Who cannot join

  • Pregnant or breastfeeding women
  • Patients who cannot tolerate raising both arms above their head (position for obtaining mobile-CT images)
  • Patients with any contraindication for general anesthesia (e.g., severe and active coronary artery disease, chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) < 1 liter, uncontrolled hypertension, increased intracranial pressure, history of intolerance to general anesthesia)
  • Dementia or other severe cognitive impairment causing inability to understand or consent to the procedure and study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Mobile-CT-Assisted Bronchoscopy

This study investigates whether using a mobile-CT-assisted bronchoscopy (M-CAB) during a bronchoscopy procedure will better enable the study staff to reach the lung tumor, perform a biopsy, and obtain a diagnosis. One method that doctors use for diagnosing lung tumors is bronchoscopy guided by an X-ray machine (called fluoroscope). Though much better guidance could be provided with a CT scanner when compared to the fluoroscope, the standard CT equipment is very large, fixed in a radiology room, and difficult to use with bronchoscopy. Mobile CT imaging systems may more easily and effectively perform the same tasks of the standard CT imaging in the bronchoscopy room, offering better guidance than the standard fluoroscope.

Read the detailed description

PRIMARY OBJECTIVE

  1. To determine the added value of mobile-CT)-assisted bronchoscopy (M-CAB) for the diagnosis of peripheral lung nodules defined as the proportion of patients in whom bronchoscopy with radial-probe endobronchial ultrasound (RP-EBUS) and 2-D Fluoroscopy is non-diagnostic (lesion is not reached or rapid-onsite cytology is non-diagnostic) and diagnosis is obtained after utilizing mobile-CT assistance.

SECONDARY OBJECTIVES:

  1. Describe the navigational yield of bronchoscopy with RP-EBUS/2-dimensional (2-D) fluoroscopy for peripheral nodules.

II. Describe the diagnostic yield of bronchoscopy with RP-EBUS/2-D fluoroscopy for peripheral nodules.

III. Describe the mobile-CT (M-CT) added navigational yield. IV. Describe the sensitivity for malignancy of bronchoscopy with RP-EBUS/2-D fluoroscopy and its increase (if any) provided by mobile-CT assistance.

  1. Describe anatomical and procedural characteristics that can influence navigational and diagnostic yield (tumor location, tumor characteristics -solid, semisolid-, air-bronchus sign, biopsy tool, relationship between biopsy tool/tumor).

VI. Describe procedure duration. VII. Describe time required to obtain mobile CT scans VIII. Describe fluoroscopy time and estimate radiation dose to the patient. IX. Describe procedural complications.

OUTLINE:

Patients undergo RP-EBUS bronchoscopy per standard of care. If the study staff cannot reach the target lesion or is unable to determine a diagnosis, patients undergo bronchoscopy using mobile CT imaging. Patients' medical records are also reviewed for up to 6 months.

Conditions
Lung Neoplasm
Being tested
Computed Tomography, Electronic Health Record Review, Endobronchial Ultrasound Bronchoscopy
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography

    Undergo mobile CT-assisted bronchoscopy

  • Electronic Health Record ReviewOther

    Patients' medical records are reviewed

  • Endobronchial Ultrasound BronchoscopyProcedure or surgery

    Also called EBUS, Endobronchial Ultrasound

    Undergo radial probe EBUS

Study groups in NCT04995172
Study groupRoleWhat they receive
Observational (CT-assisted bronchoscopy, chart review)Patients undergo RP-EBUS bronchoscopy per standard of care. If the study staff cannot reach the target lesion or is unable to determine a diagnosis, patients undergo bronchoscopy using mobile CT imaging. Patients' medical records are also reviewed for up to 6 months.
Receives: Procedure: Computed Tomography; Other: Electronic Health Record Review; Procedure: Endobronchial Ultrasound Bronchoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The added value of mobile-computed tomography (CT)-assisted bronchoscopy (M-CAB)

    Defined as the proportion of patients in whom bronchoscopy with thin or ultrathin scope, radial-probe endobronchial ultrasound (RP-EBUS) and 2-dimensional (2-D) fluoroscopy is non-diagnostic (lesion is not reached or rapid-onsite cytology is non-diagnostic) and diagnosis is obtained after utilizing mobile-CT assistance. Descriptive statistics (mean standard deviation [SD] or median interquartile range [IQR], frequency [%]) will be used to summarize patient characteristics.

    Measured: Up to 6 months

Secondary outcomes (10)

  1. Navigational yield of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy for peripheral nodules

    Navigational yield for standard of care (SOC) will be estimated along with 95% confidence intervals (CIs).

    Measured: Up to 6 months

  2. Diagnostic yield of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy for peripheral nodules

    Diagnostic yield of SOC and diagnostic yield of SOC + M-CT along with their 95% CIs will be estimated.

    Measured: Up to 6 months

  3. Mobile-CT (M-CT) added navigational yield

    M-CT added diagnostic yield in a subgroup with non-diagnostic subjects by SOC will be estimated along with its 95% CI. M-CT added diagnostic yield in a subgroup with non-diagnostic subjects by SOC will be estimated along with its 95% CI. Two-sided exact binomial test will be used to test if diagnostic yield of SOC + M-CT is significantly different from 0.2 in the subgroup.

    Measured: Up to 6 months

  4. Sensitivity for malignancy of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy and its increase (if any) provided by mobile-CT assistance

    Sensitivity for malignancy of SOC and sensitivity for malignancy of SOC + M-CT will be estimated, considering final pathology as the gold standard test.

    Measured: Up to 6 months

  5. Anatomical and procedural characteristics that can influence navigational and diagnostic yield

    Anatomic and procedural characteristics that are associated with navigational and diagnostic yield will be evaluated by multivariate logistic regression models. A p-value of less than 0.05 will indicate a statistical significance.

    Measured: Up to 6 months

  6. Procedure duration

    Will be summarized by mean (standard deviation [SD]) or median (interquartile range [IQR]).

    Measured: Up to 6 months

  7. Time required to obtain mobile CT scans

    Will be summarized by mean (SD) or median (IQR).

    Measured: Up to 6 months

  8. Fluoroscopy time

    Will be summarized by mean (SD) or median (IQR).

    Measured: Up to 6 months

  9. Radiation dose to the patient

    Will be summarized by mean (SD) or median (IQR).

    Measured: Up to 6 months

  10. Procedural complications

    Complications will be tabulated.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2021
  2. Study start19 Apr 2021
  3. Primary completion27 Nov 2024
  4. Study completion27 Nov 2024

Resources

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
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04995172
Sponsor's protocol ID
2020-0760
Other IDs
NCI-2021-01331, 2020-0760
Status last verified
Dec 2024
First submitted
28 Jul 2021
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Neoplasm, 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 1 inclusion and 4 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 4 Dec 2024. 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?

The added value of mobile-computed tomography (CT)-assisted bronchoscopy (M-CAB) (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04995172.

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 4 Dec 2024.

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