The Feasibility of Low Dose Chest CT for Virtual Bronchoscopy Navigation

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2021-12-30

Brief Summary

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Advances in medical imaging technology have made it possible to detect patients with small-sized lung lesions early. Generally, invasive methods such as PCNA were used to diagnose peripheral lung nodule. However, Radial probe endobronchial ultrasonography (RP-EBUS) is widely used in the histological diagnosis of peripheral lung nodule in recent years. In order to carry out RP-EBUS, it is necessary to know the path to the lesion to access it. Conventionally, the path to the peripheral lung nodule is identified by the drawing, but recently, the path is reviewed by the virtual bronchoscopy navigation (VBN) which is reconstructed 3-dimension image using the CT data. Currently, VBN is driven by using raw data acquired using standard thin sectioned chest CT protocol, but the problem is that additional doses of radiation are exposed to patients who have initially discovered lung lesions using low dose CT. Therefore, we conduct a randomized controlled trial to verify the suitability of VBN using the raw data acquired by low dose CT.

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Detailed Description

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The standard thin sectioned protocol CT consists of scout, enhanced and non-enhanced image. Therefore, in this study, non-enhanced protocol CT was taken with low dose protocols with three different radiation doses to acquire raw data and drive VBN, and compared with the VBN result driven with raw data obtained with standard protocol. The primary endpoint of this study is to verify the consistency and accuracy of the VBN results driven by the raw data obtained with the low dose protocol CT.

Conditions

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Bronchoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Low dose chest CT simulation

VBN result driven using raw data acquired with low dose CTs taken with three different protocols

Group Type EXPERIMENTAL

Chest CT

Intervention Type DIAGNOSTIC_TEST

Low dose CT taken with three different protocols

Standard protocol chest CT simulation

VBN result driven using raw data acquired with standard protocol CT

Group Type ACTIVE_COMPARATOR

Chest CT

Intervention Type DIAGNOSTIC_TEST

Low dose CT taken with three different protocols

Interventions

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Chest CT

Low dose CT taken with three different protocols

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patients older than 18 years
2. Competent to give informed consent
3. Patients requiring a pathological diagnosis of pulmonary nodules using RP-EBUS.
4. Patients who need chest CT before RP-EBUS.