The Feasibility of Low Dose Chest CT for Virtual Bronchoscopy Navigation - Human Study.

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Feasibility of Low Dose Chest CT for Virtual Bronchoscopy Navigation in Human Patients.

Conditions
-----------------
Bronchoscopy

Intervention / Treatment
-----------------
* Diagnostic Test: Chest CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years Competent to give informed consent Patients requiring a pathological diagnosis of pulmonary nodules using RP-EBUS. Patients who need chest CT before RP-EBUS. Exclusion Criteria: Pregnancy Patients who could not receive chest CT Inability to obtain informed consent Patients unable to perform RP-EBUS

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose chest CT simulation<br>VBN result driven using raw data acquired with low dose CTs taken with three different protocols | Diagnostic Test: Chest CT<br>* Low dose CT taken with three different protocols<br>|
| Active Comparator: Standard protocol chest CT simulation<br>VBN result driven using raw data acquired with standard protocol CT | Diagnostic Test: Chest CT<br>* Low dose CT taken with three different protocols<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance rate of VBN simulation results | Concordance rate comparing the VBN result driven based on raw data acquired with low dose CTs taken with three different protocols compared to the VBN result driven based on raw data obtained with standard protocol CT. | From CT scan to VBN drive (an average of 1 week) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Computer simulation, Multislice computed tomography