CBCT in Guiding Bronchoscopy in Patients With Lung Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-28

Study Completion Date

2019-05-04

Brief Summary

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This pilot clinical trial studies how well cone-beam computed tomography (CBCT) works in guiding bronchoscopy in patients with lung lesions. CBCT during bronchoscopy may help doctors to biopsy lung lesions that are harder to reach.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To describe the feasibility of using CBCT as an additional aid to guided-bronchoscopy with radial probe endobronchial ultrasound (RP-EBUS)/hybrid scope for the diagnosis of peripheral lung nodules.

SECONDARY OBJECTIVES:

I. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is identified by RP-EBUS (RP-EBUS-navigation yield) and confirmed with CBCT.

II. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is identified by RP-EBUS and samples are diagnostic (diagnostic yield-RP-EBUS).

III. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is identified by RP-EBUS, samples were non-diagnostic, and CBCT prompted further tool re-location (i.e. change of needle angle, change of tool) leading to diagnosis.

IV. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is not identified by RP-EBUS, and CBCT-aided navigation allowed the operator to reach the lesion (CBCT-added navigation yield).

V. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is not identified by RP-EBUS and CBCT-aided navigation allowed the operator to reach the lesion and obtain a diagnosis (CBCT-added diagnostic yield).

VI. Describe the relationship between RP-PROBE and target (contact/no contact; central/peripheral).

VII. Describe the relationship between needle tip and target (contact/no contact; central/peripheral).

VIII. Describe the influence of points 6 and 7 on diagnostic yield. IX. Describe fluoroscopy time. X. Describe estimated amount of radiation generated by CBCT use. XI. Describe bronchoscopy time (first scope in/last scope out). XII. Describe the proportion of patients in whom molecular analysis for lung cancer (i.e. EGFR, K-RAS, ALK) can be performed.

OUTLINE:

Patients undergo CBCT during standard of care bronchoscopy.

After completion of study, patients with lesions found not to be cancerous are followed up for 6 months to watch for changes (standard care).

Conditions

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Pulmonary Mass

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (CBCT)

Patients undergo CBCT during standard of care bronchoscopy.

Group Type EXPERIMENTAL

Cone-Beam Computed Tomography

Intervention Type PROCEDURE

Undergo CBCT

Interventions

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Cone-Beam Computed Tomography

Undergo CBCT

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing guided-bronchoscopy for diagnosis of peripheral lung lesion/s \> 1 and \< 3 cm in diameter located in the outer 2/3 of the lung fields

Exclusion Criteria

* Pregnant or breastfeeding women
* Patient with indications for mediastinal lymph node (LN) sampling per 13th American College of Clinical Pharmacy (ACCP) guidelines
* Patient with metastatic disease (from primaries other than lung) who have suspicious mediastinal or hilar LN that require sampling
* Patients with contraindication/s 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No